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Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir alafenamide in a once daily pill (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 19, 2017 Category: Pharmaceuticals Source Type: news

FDA Advisory Committee Unanimously Recommends Approval of Investigational Luxturna (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease
PHILADELPHIA, Oct. 12, 2017 (GLOBE NEWSWIRE) -- Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that the U.S. Food and Drug Administration ’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 19, 2017 Category: Drugs & Pharmacology Source Type: news

Novo Nordisk Receives Positive 16-0 vote from FDA Advisory Committee in Favor of Approval for Semaglutide
PLAINSBORO, N.J., Oct. 18, 2017 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 18, 2017 Category: Drugs & Pharmacology Source Type: news

FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants Priority Review
AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. (Source: World Pharma News)
Source: World Pharma News - October 18, 2017 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

FDA grants priority review for Exelixis ’ Cabometyx to treat advanced RCC
The US Food and Drug Administration (FDA) has granted a priority review for the US-based drug discovery company Exelixis ’ supplemental new drug application (sNDA) for cabometyx (cabozantinib) to treat patients with previously untreated advanced renal… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 17, 2017 Category: Pharmaceuticals Source Type: news

Charleston Laboratories, Inc. Resubmits NDA for CL-108
Jupiter, Florida ─ October 17, 2017 ─ Charleston Laboratories, Inc. announced today that it resubmitted the new drug application (NDA) for its novel investigational treatment, CL-108, for the relief of moderate to severe acute pain while... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2017 Category: Drugs & Pharmacology Source Type: news

Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA
JERUSALEM--(BUSINESS WIRE)--Oct. 17, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Committee Backs Netarsudil, a Once-Daily Glaucoma Drug FDA Committee Backs Netarsudil, a Once-Daily Glaucoma Drug
The FDA advisory committee approved a new drug application for once-daily glaucoma drug netarsudil (Rhopressa), introducing a new drug class for this indication.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 16, 2017 Category: Consumer Health News Tags: Ophthalmology News Source Type: news

Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa (netarsudil ophthalmic solution) 0.02%
IRVINE, Calif.--(BUSINESS WIRE)--Oct. 13, 2017-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 13, 2017 Category: Drugs & Pharmacology Source Type: news

Nasdaq halts trading of Aerie stock as FDA reviews Rhopressa NDA
Aerie Pharmaceuticals (NSDQ:AERI) said today that Nasdaq has halted trading of the company’s common stock as an FDA committee convenes to review Aerie’s new drug application for its Rhopressa glaucoma and ocular hypertension drug. The Irvine, Calif.-based company submitted the NDA in February and the FDA is slated to finishing reviewing the application by Feb. 28, 2018. Get the full story at our sister site, Drug Delivery Business News. The post Nasdaq halts trading of Aerie stock as FDA reviews Rhopressa NDA appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Wall Street Beat Aerie Pharmaceuticals Source Type: news

AcelRx shares tumble after FDA rejects Dsuvia painkiller
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) fell more than -50% this morning after the company announced that it received a complete response letter from the FDA for its Dsuvia sufentanil sublingual tablet. The FDA told the company that it can’t approve the new drug application in its present form, saying that AcelRx needs to collect additional data for at least 50 patients to assess the safety of the painkiller’s maximum dose described in its proposed labeling. Get the full story at our sister site, Drug Delivery Business News. The post AcelRx shares tumble after FDA rejects Dsuvia painkiller appear...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat AcelRx Source Type: news

FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
INDIANAPOLIS, Oct. 12, 2017 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verz... Biopharmaceuticals, Oncology, FDA Eli Lilly, Verzenio, abemaciclib, breast cancer, metastatic breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 12, 2017 Category: Pharmaceuticals Source Type: news

AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA
REDWOOD CITY, Calif., Oct. 12, 2017 /PRNewswire/-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 12, 2017 Category: Drugs & Pharmacology Source Type: news

Janssen Biotech submits NDA to FDA for apalutamide to treat non-metastatic CRPC
Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide to treat male patients with non-metastatic castration-resistant prostate cancer (CRPC). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 11, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk for Metastasis (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 11, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High Risk for Metastasis HORSHAM, Pa., Oct. 11, 2017 -- (Healthcare Sales & Marketing Network) -- Janssen Biotech, Inc. today announced that it ha... Biopharmaceuticals, Oncology, FDA Janssen, apalutamide, prostate cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 11, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
HORSHAM, PA, October 11, 2017 – Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 11, 2017 Category: Drugs & Pharmacology Source Type: news

Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Potential First-in-Class, Oral Treatment for a Condition Affecting an Estimated 26 Million U.S. Women(1) If Approved, First Oral Therapy to Demonstrate Efficacy and Safety for Uterine Fibroids in Two U.S. Pivotal Studies DUBLIN, Oct. 10, 2017 -- (Hea... Biopharmaceuticals, FDA Allergan, ulipristal, uterine fibroids (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 10, 2017 Category: Pharmaceuticals Source Type: news

America & #039;s Blood Supply Can Now Be Screened for Zika
America’s blood supply is better protected from the Zika virus, now that FDA has approved the first test designed to detect the virus in blood donations. Learn about the IVD market at BIOMEDevice San Jose, Dec. 6-7, 2017.  The cobas Zika test from Roche has already been used by several U.S. blood collection establishments under an investigational new drug application (IND). The test can also screen for the virus RNA in specimens collected from living organ donors. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Pet...
Source: MDDI - October 10, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Regulatory and Compliance Source Type: news

Zydus Cadila gets USFDA nod to market antidepressant drug
"The group now has more than 160 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company," it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 7, 2017 Category: Pharmaceuticals Source Type: news

Janssen submits sNDA to FDA for Invokana to reduce risk of MACE
Janssen Research and Development has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 4, 2017 Category: Pharmaceuticals Source Type: news

US FDA approves Takeda ’s sNDA for new dose regimen of Alunbrig 180mg tablets
The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical Company ’s supplemental new drug application (sNDA) for 180mg Alunbrig tablets to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lun… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 3, 2017 Category: Pharmaceuticals Source Type: news

US FDA grants priority review status to Allergan ’s sNDA for Avycaz
The US Food and Drug Administration (FDA) has granted priority review status for Allergan ’s supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam) to treat hospital-acquired bacterial pneumonia / ventilator-associated bacteri… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 2, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA ® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program
Filing includes data on the combined risk reduction of cardiovascular death, myocardial infarction and stroke in patients with type 2 diabetes (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 2, 2017 Category: Pharmaceuticals Source Type: news

Rigel Provides Update on FDA Review of Fostamatinib for ITP
SOUTH SAN FRANCISCO, Calif., Oct. 2, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that during the company's mid-cycle meeting with the U.S. Food and Drug Administration (FDA) the FDA indicated that, at this point,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 2, 2017 Category: Drugs & Pharmacology Source Type: news

Kitov Announces Filing by FDA of New Drug Application for KIT-302
TEL AVIV, Israel, October 2, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) filed the Company's New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 2, 2017 Category: Drugs & Pharmacology Source Type: news

Auburn therapeutic company receives FDA drug approval
Vitruvias Therapeutics LLC, an Auburn-based drug company, has received approval of a new drug application from the U.S. Food and Drug Administration for a new drug. Vitruvias developed the drug with Sunny Pharmtech, a Taiwan-based API and drug development company. Sunny Pharmtech leaders said the jointly filed application received approval quickly. The drug, lidocaine ointment USP 5 percent, is the first generic approval for both companies and is also part o f a joint development agreement that… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 29, 2017 Category: Health Management Authors: Tyler Patchen Source Type: news

Auburn therapeutic company receives FDA drug approval
Vitruvias Therapeutics LLC, an Auburn-based drug company, has received approval of a new drug application from the U.S. Food and Drug Administration for a new drug. Vitruvias developed the drug with Sunny Pharmtech, a Taiwan-based API and drug development company. Sunny Pharmtech leaders said the jointly filed application received approval quickly. The drug, lidocaine ointment USP 5 percent, is the first generic approval for both companies and is also part o f a joint development agreement that… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 29, 2017 Category: Biotechnology Authors: Tyler Patchen Source Type: news

INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA
PHOENIX, Sept. 29, 2017 (GLOBE NEWSWIRE) -- In advancing its pipeline of innovative medicines, INSYS Therapeutics, Inc. (NASDAQ:INSY) ( “INSYS” or “the company”), announced today that it filed a New Drug Application (NDA) for a novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2017 Category: Drugs & Pharmacology Source Type: news

Allergan receives FDA ’s RTF letter for Vraylar sNDA to treat schizophrenia
Allergan ’s supplemental new drug application (sNDA) for Vraylar (cariprazine) to treat negative symptoms associated with schizophrenia in adult patients has received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 25, 2017 Category: Pharmaceuticals Source Type: news

Following IPO, Dova puts lead drug in FDA ’s hands
Following its initial public offering – which yielded net proceeds of about $80 million – Durham-based Dova Pharmaceuticals has submitted a new drug application to the U.S. Drug Administration for its lead drug. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 25, 2017 Category: Health Management Authors: Jennifer Henderson Source Type: news

Lannett's Board Of Directors Initiates CEO Search
CEO Arthur Bedrosian to Step Down Upon Naming of a Successor Company Submits 505(b)(2) New Drug Application for Its Proprietary Anesthetic Product, Cocaine Hydrochloride (HCl) Topical Solution PHILADELPHIA, Sept. 25, 2017 -- (Healthcare Sales & Marke... Biopharmaceuticals, Generics, Personnel, FDA Lannett Company, Cocaine HCl (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 25, 2017 Category: Pharmaceuticals Source Type: news

Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA
TORONTO, Sept. 25, 2017 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) ( " Intellipharmaceutics " or the " Company " ), a pharmaceutical company specializing in the research, development and manufacture of novel and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2017 Category: Drugs & Pharmacology Source Type: news

Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status
HAYWARD, Calif.--(BUSINESS WIRE) September 25, 2017 -- Aradigm Corporation (NASDAQ: ARDM) (the " Company " ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2017 Category: Drugs & Pharmacology Source Type: news

Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application
HORSHAM, PA, September 22, 2017 – Janssen Biotech, Inc. (Janssen) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2017 Category: Drugs & Pharmacology Source Type: news

BioCryst scores FDA approval on flu treatment for children
On the heels of an $80 million public offering, Research Triangle Park-based BioCryst Pharmaceuticals (Nasdaq: BCRX) has landed U.S. Food and Drug Administration approval for its injectable flu treatment in pediatric patients. BioCryst submitted its supplemental new drug application for RAPIVAB (peramivir injection) earlier this year, with the FDA ultimately granting a priority review. In 2014, the FDA approved RAPIVAB for treating adults with the flu and the firm has also been approved in a number… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2017 Category: Biotechnology Authors: Jennifer Henderson Source Type: news

Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
YARDLEY, Pa.--(BUSINESS WIRE)-- September 18, 2017 -- Optinose, an ENT / Allergy specialty pharmaceutical company, announced today that the U.S. Food& Drug Administration (FDA) approved the Company ’s New Drug Application (NDA) for Xhance... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 19, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease
CRANBURY, N.J., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the oral precision medicine migalastat for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 19, 2017 Category: Drugs & Pharmacology Source Type: news

Glenmark looks to file up to 25 product applications annually
We expect to file 20-25 abbreviated new drug applications each year over the next 5 years and launch 10-20 products annually," Glenmark MD Glenn Saldanha said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2017 Category: Pharmaceuticals Source Type: news

Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder
Lund, Sweden – 18 September 2017 — Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for weekly and monthly CAM2038 buprenorphine depots for the treatment of adults... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults
Atlanta, Georgia (U.S.)& Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Briviact (brivaracetam) CV as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 15, 2017 Category: Drugs & Pharmacology Source Type: news

Janssen Submits Supplemental New Drug Application to U.S. FDA for ZYTIGA ® (abiraterone acetate) to Treat Men with Earlier Stages of Metastatic Prostate Cancer
Filing Supported by Data from Pivotal LATITUDE Trial Evaluating ZYTIGA ® in Combination with Prednisone and Androgen Deprivation Therapy (ADT) (Source: Johnson and Johnson)
Source: Johnson and Johnson - September 14, 2017 Category: Pharmaceuticals Source Type: news

Sunovion ’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
MARLBOROUGH, Mass.--(BUSINESS WIRE)--September 14, 2017 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the indication for its... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes Unanimously for Shingrix (HZ/su) in the US for Prevention of Herpes Zoster (Shingles) in Adults Ages 50 and Over
London UK 13 September 2017 -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 13, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Acknowledges Receipt of Sorrento Therapeutics Inc, NDA for ZTlido
SAN DIEGO, Sept. 12, 2017 /PRNewswire/ -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, " Sorrento " ), announced today that SCILEX Pharmaceuticals Inc. ( " SCILEX " ), a majority-owned subsidiary of Sorrento, has received from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2017 Category: Drugs & Pharmacology Source Type: news

AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
In clinical studies, elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated pain - daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse Endometriosis affects an estimated one i... Biopharmaceuticals, FDA AbbVie, elagolix, endometriosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 6, 2017 Category: Pharmaceuticals Source Type: news

AbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
NORTH CHICAGO, Ill., Sept. 6, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that it has submitted a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 6, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion submits NDA for dasotraline to US FDA to treat ADHD patients
Sunovion Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline to treat patients with attention deficit hyperactivity disorder (ADHD). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news

Sanofi Receives Tentative FDA Approval of Admelog (insulin lispro injection) 100 units/mL
BRIDGEWATER, N.J., Sept. 1, 2017 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog ® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2017 Category: Drugs & Pharmacology Source Type: news

SteadyMed shares tumble after FDA refuses to review Trevyent NDA
Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the second RTF letter issued by the FDA this week, the first to Acorda Therapeutics on Tuesday. SteadyMed submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional desig...
Source: Mass Device - August 31, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) SteadyMed Therapeutics Source Type: news