$5.1 million grant will fund research to develop stem cell-based therapy for blinding eye conditions
Scientists at the UCLA  Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions.The award by the California Institute for Regenerative Medicine, or CIRM, will support the development of a treatment that will use patients ’ own skin cells to generate autologous induced pluripotent stem cells to derive retinal pigment epithelium cells, which are lost in many blinding eye conditions....
Source: UCLA Newsroom: Health Sciences - October 19, 2018 Category: Universities & Medical Training Source Type: news

AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
If granted, IMBRUVICA plus obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for first-line CLL treatment The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which sho... Biopharmaceuticals, Oncology, FDA AbbVie, IMBRUVICA, ibrutinib, obinutuzumab (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 17, 2018 Category: Pharmaceuticals Source Type: news

Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala is positioning its drug as a tool to help manage dry eye flares and other conditions associated with dry eye disease. Get the full story at our sister site, Drug Delivery Business News. The post Kala seeks FDA nod for dry eye disease drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat Kala Pharmaceuticals Source Type: news

FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
REDWOOD CITY, Calif., Oct. 12, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, announced today that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 12, 2018 Category: Drugs & Pharmacology Source Type: news

FDA advisory committee recommends not approving Trevena pain drug
A Food and Drug Administration advisory committee, in a close vote, recommended not approving a new drug application submitted by Trevena Inc. for its experimental pain medicine Olinvo. The vote by the federal agency’s Anesthetic and Analgesic Drug Products Advisory Committee was eight against, and seven in favor of, supporting the approval of the application. The FDA is not required to follow the recommendations of its advisory panels, though it typically does. “We continu e to believe that… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 12, 2018 Category: American Health Authors: John George Source Type: news

FDA Approves Stiolto(R) Respimat(R) Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction
Stiolto Respimat is the first in its class to have exacerbation data in the product labeling RIDGEFIELD, Conn., Oct. 11, 2018 -- (Healthcare Sales & Marketing Network) -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (... Biopharmaceuticals, Drug Delivery, FDA Boehringer Ingelheim, Stiolto Respimat, tiotropium, olodaterol, COPD (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 11, 2018 Category: Pharmaceuticals Source Type: news

FDA lifts hold on CRISPR, Vertex sickle cell trial
CRISPR Therapeutics and Vertex Pharmaceuticals announced that the U.S. FDA has lifted the clinical hold and accepted the Investigational New Drug application for a new treatment for sickle cell disease. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 11, 2018 Category: Pharmaceuticals Source Type: news

Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
October 11, 2018 -- Trevena, Inc. (NASDAQ: TRVN), today announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 11, 2018 Category: Drugs & Pharmacology Source Type: news

OSE Immunotherapeutics and Oncology Physician Network GERCOR Announce Submission of Investigational New Drug Application to Evaluate Tedopi(R) in Combination with Nivolumab in Pancreatic Cancer
The Phase 2 clinical trial of Tedopi® in pancreatic cancer will be sponsored by the oncology group GERCOR The study will explore Tedopi®’s potential in an additional oncology indication NANTES, France, Oct. 10, 2018 -- (Healthcare Sales & Mar... Biopharmaceuticals, Oncology, Regulatory OSE Immunotherapeutics, Tedopi, pancreatic cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 10, 2018 Category: Pharmaceuticals Source Type: news

Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
LAVAL, Quebec, Oct. 8, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 9, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)
Basel, October 08, 2018 - Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's New Drug Application (NDA) and Marketing Authorization Application (MAA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 8, 2018 Category: Drugs & Pharmacology Source Type: news

Take two: Recro tries for second time to get FDA approval for its non-opioid pain medicine
Recro Pharma Inc. is getting another shot at getting its lead new drug candidate approved by the Food and Administration. In May, the FDA rejected the Malvern, Pa., specialty pharmaceutical company's new drug application for its experimental, non-opioid pain medicine called intravenous meloxicam. On Monday, Recro (NASDAQ: REH) announced the federal agency has set March 24, 2019, as the new target date for making a d ecision on the company's resubmitted application that it said addresses the concerns… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - October 8, 2018 Category: Health Management Authors: John George Source Type: news

U.S. FDA Announces Joint Advisory Committee Review of Mallinckrodt's Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone(R) (Oxycodone Hydrochloride)
Company Seeks Approval of New Drug Application for MNK-812 Through 505(b)2 Regulatory Pathway STAINES-UPON-THAMES, United Kingdom, Oct. 8, 2018 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharma... Biopharmaceuticals, Drug Delivery, FDA Mallinckrodt, Roxicodone, Oxycodone (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 8, 2018 Category: Pharmaceuticals Source Type: news

FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
Cambridge, UK and Indianapolis, US – 8 October 2018: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 8, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Karyopharm ’s New Drug Application for Selinexor and Grants Priority Review
NEWTON, Mass., Oct. 05, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency
London, UK, 1st October 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients ’ unmet medical needs, today announces that it has received confirmation... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves KYPROLIS ® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma
Approval of a More Convenient Once-Weekly Kd70 Regimen Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study Application Granted Priority Review Designation Application Reviewed and Approved Under FDA's Real-Time Oncology Review and Assessment Aid Pilot Programs THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly...
Source: Amgen News Release - October 1, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
NEW YORK, Sept. 28, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
SAN DIEGO, CA – Sept. 25, 2018 -- Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Valtoco (diazepam nasal spray) as a treatment for epilepsy patients... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2018 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
(Source: Johnson and Johnson)
Source: Johnson and Johnson - September 19, 2018 Category: Pharmaceuticals Source Type: news

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
HORSHAM, Pa., Sept. 18, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 18, 2018 Category: Drugs & Pharmacology Source Type: news

Ardelyx Submits New Drug Application for Tenapanor for IBS-C
FREMONT, Calif., Sept. 13, 2018 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authorization of tenapanor for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 13, 2018 Category: Drugs & Pharmacology Source Type: news

Ardelyx Submits New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C to U.S. Food and Drug Administration
FREMONT, Calif., Sept. 13, 2018 -- (Healthcare Sales & Marketing Network) -- Ardelyx, Inc. (Nasdaq : ARDX ), today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authoriz... Biopharmaceuticals, Gastroenterology Ardelyx, tenapanor, IBS-C, irritable bowel syndrome (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 13, 2018 Category: Pharmaceuticals Source Type: news

Acorda Announces FDA Extends Inbrija NDA Review Period
ARDSLEY, N.Y.--(BUSINESS WIRE)--September 13, 2018 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 13, 2018 Category: Drugs & Pharmacology Source Type: news

Berwyn pharma firm gets approval for ALS drug
The Food and Drug Administration has approved ITF Pharma ’s new drug application for Tiglutik, a treatment for amyotrophic lateral sclerosis or ALS. Tiglutik is, according to ITF Pharma, the first and only easy-to-swallow thickened riluzole liquid for ALS. The medicine is administered twice daily by oral syringe. ALS, also known as Lou Gehrig’s dise ase, is a progressive and ultimately fatal neurodegenerative disease marked by a gradual degeneration of nerve cells of the central nervous system… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 6, 2018 Category: Biotechnology Authors: John George Source Type: news

Recro Pharma to resubmit application for non-opioid pain medicine
Recro Pharma Inc. said Tuesday it expects to resubmit its new drug application for its lead product candidate, a non-opioid pain medicine, by the end of this month. In May, the Food and Drug Administration rejected the Malvern specialty pharmaceutical company's application seeking approval to market intravenous meloxicam for the management of moderate-to-severe pain. In its response letter, the FDA said the data suggested that the analgesic effect of the the rapy did not meet the agency's expectations. In… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 4, 2018 Category: American Health Authors: John George Source Type: news

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
(Source: Johnson and Johnson)
Source: Johnson and Johnson - September 4, 2018 Category: Pharmaceuticals Source Type: news

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
September 04, 2018 The Janssen Pharmaceutical Companies of Johnson& Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 4, 2018 Category: Drugs & Pharmacology Source Type: news

Biologicals_BeiGene_NDA_China
Boehringer Ingelheim Biopharmaceuticals China supports BeiGene in its China NDA submission of anti-PD-1 antibody, tislelizumabFirst biologic manufactured by Boehringer Ingelheim BioChina accepted for New Drug Application reviewImportant milestone for Boehringer Ingelheims ’ collaboration partner BeiGene in immuno-oncologyBoehringer Ingelheim BioChina is proud to support BeiGene in serving patients worldwide with this important medicine   (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - September 3, 2018 Category: Research Source Type: news

FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 31, 2018 Category: Drugs & Pharmacology Source Type: news

The Line Between Drugs and Devices Continues to Blur
Otsuka America Pharmaceutical has signed a collaboration agreement with Magellan Health designed to facilitate access to the first drug-device combination product approved by FDA to track drug ingestion. The agreement creates an opportunity for doctors and adult patients to gather experience in a real-world setting with the Abilify Mycite System, Princeton, NJ-based Otsuka said on Thursday. The Abilify Mycite System is the perfect example of how the line between pharma and medtech continues to blur, which isn't necessarily a bad thing. The product is comprised of Otsuka's oral aripiprazole tablets embedded with...
Source: MDDI - August 30, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Amgen Submits Supplemental New Drug Application For KYPROLIS ® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone
Filing Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study THOUSAND OAKS, Calif., Aug. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) ...
Source: Amgen News Release - August 27, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA
CAMBRIDGE, Mass. and CARLSBAD, Calif., Aug. 27, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA) an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), today announced that they received a Complete... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 27, 2018 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter
STAINES-UPON-THAMES, United Kingdom, Aug. 22, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, confirmed today that it has received a Complete Response Letter from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 22, 2018 Category: Drugs & Pharmacology Source Type: news

Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application
DUBLIN, Aug. 21, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Evoke Pharma ’s Gimoti NDA Accepted for FDA Review
SOLANA BEACH, Calif., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company ’s 505(b)(2) New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion
LAVAL, Quebec, Aug. 15, 2018 /PRNewswire/ -- Ortho Dermatologics, a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food& Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
Brussels (Belgium)& Atlanta Georgia, August 13th 07:00 (CEST): UCB today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for midazolam nasal spray*, an investigational product... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends Approval of Paratek ’s Omadacycline
BOSTON, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the Antimicrobials Drug Advisory Committee of the U.S. Food and Drug Administration voted in favor of the approval of intravenous (IV) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA rejects Pain Therapeutics' lead drug, shares tumble
Pain Therapeutics Inc. is undergoing a major overhaul after the U.S. Food and Drug Administration rejected its new drug application for Remoxy, an extended-release and tamper-resistant version of the painkiller oxycodone. The Austin-based drugmaker said Monday in a securities filing it would shift its focus from painkillers to treatments for Alzheimer's disease. That comes after Pain Therapeutics (Nasdaq: PTIE) heard from the FDA that Remoxy data "do not support the conclusion" that its benefits… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 7, 2018 Category: Pharmaceuticals Authors: Will Anderson Source Type: news

Complete Response Letter Issued for Remoxy
AUSTIN, Texas, Aug. 06, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 6, 2018 Category: Drugs & Pharmacology Source Type: news

United Therapeutics Announces FDA Approval of the Implantable System for Remodulin
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 31, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 31, 2018 Category: Drugs & Pharmacology Source Type: news

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
NKTR-181 is a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy SAN FRANCISCO, July 30, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company's New Drug Application (NDA) for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. NKTR-181 is a new molecular entity...This story is related to the following:Prescription Drugs (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - July 31, 2018 Category: Medical Devices Source Type: news

FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis
ROCKLAND, Mass., July 30, 2018 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 30, 2018 Category: Drugs & Pharmacology Source Type: news

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
SAN FRANCISCO, July 30, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company's New Drug Application (NDA) for NKTR-181 for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 30, 2018 Category: Drugs & Pharmacology Source Type: news

INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA
PHOENIX, July 27, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ: INSY) announced that today it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company ’s New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2018 Category: Drugs & Pharmacology Source Type: news

Durham pharma could be on its way to second FDA approval
Durham-based Aerie Pharmaceuticals (Nasdaq: AERI) could be well on its way to a second U.S. Food and Drug Administration approval.   The FDA has accepted Aerie’s new drug application (NDA) submission for the company’s second glaucoma drug, Roclatan, earlier than expected.  Aerie said this week that the FDA has set a goal date for completion of the agency’s review of the Roclatan NDA of March 14, 2019. The NDA acceptan ce comes less than three months after Aerie said it had launched its first… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - July 26, 2018 Category: Health Management Authors: Jennifer Henderson Source Type: news

Durham pharma could be on its way to second FDA approval
Durham-based Aerie Pharmaceuticals (Nasdaq: AERI) could be well on its way to a second U.S. Food and Drug Administration approval.   The FDA has accepted Aerie’s new drug application (NDA) submission for the company’s second glaucoma drug, Roclatan, earlier than expected.  Aerie said this week that the FDA has set a goal date for completion of the agency’s review of the Roclatan NDA of March 14, 2019. The NDA acceptan ce comes less than three months after Aerie said it had launched its first… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 26, 2018 Category: Biotechnology Authors: Jennifer Henderson Source Type: news