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JB Chemicals & Pharma gets USFDA nod for hypertension tablets
"The USFDA has approved the company's supplementary Abbreviated New Drug Application (ANDA) for Atenolol tablets USP 25mg, 50mg and 100 mg," J B Chemicals& Pharmaceuticals said in a BSE filing today. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 13, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO ® (rivaroxaban) for Patients with Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)
(Source: Johnson and Johnson)
Source: Johnson and Johnson - December 11, 2017 Category: Pharmaceuticals Source Type: news

Fennec ’s $20M offering primes company for 2019 commercial launch
With a new drug application filing just within reach, Research Triangle Park-based Fennec Pharmaceuticals ’ (Nasdaq: FENC) $20 million public offering aims to prepare the company for a commercial launch in 2019.  Fennec – which is developing a product called PEDMARK for the prevention of hearing loss in pediatric cancer patients receiving chemotherapy – announced Friday the pricing of its public offering of about 2.3 million common shares at a price of $8.50 per share.  “The proceeds are… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 11, 2017 Category: American Health Authors: Jennifer Henderson Source Type: news

FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults
INDIANAPOLIS, Dec. 11, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) to review galcanezumab for the prevention of migraine... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 11, 2017 Category: Drugs & Pharmacology Source Type: news

Acorda resubmits NDA for inhaled Parkinson ’ s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. Get the full story at our sister site, Drug Delivery Business News. The post Acorda resubmits NDA for inhaled Parkinson’s disease therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 7, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat Acorda Therapeutics Source Type: news

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
December 5, 2017 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 5, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
MARLBOROUGH, Mass.--(BUSINESS WIRE) December 5, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 5, 2017 Category: Drugs & Pharmacology Source Type: news

GSK Submits US Regulatory Application for Single-Dose Tafenoquine for Plasmodium vivax Malaria
London, UK; Geneva, Switzerland - 28 November 2017 -- GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 28, 2017 Category: Drugs & Pharmacology Source Type: news

Zydus gets USFDA nod for seizure, migraine drug
Zydus Cadila has more than 170 approvals and has so far filed over 310 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2017 Category: Pharmaceuticals Source Type: news

Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review
DURHAM, N.C., Nov. 27, 2017 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) today announced the New Drug Application (NDA) for avatrombopag has been accepted for filing and has been granted Priority Review by the United States Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 27, 2017 Category: Drugs & Pharmacology Source Type: news

GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, 'FF/UMEC/VI') for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). (Source: World Pharma News)
Source: World Pharma News - November 23, 2017 Category: Pharmaceuticals Tags: Featured GlaxoSmithKline Business and Industry Source Type: news

U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine
LOUISVILLE, Ky., Nov. 21, 2017 /PRNewswire/ -- US WorldMeds today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine, an investigational product to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 21, 2017 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 20, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kal éo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Richmond, VA (November 20, 2017) kal éo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2017 Category: Drugs & Pharmacology Source Type: news

MMS Selected by Paratek to Support its NDA Submissions for...
MMS Holdings Inc. (MMS) announced today that it was selected by Paratek Pharmaceuticals, Inc. to support the development of its U.S. new drug applications (NDAs) for omadacycline. The omadacycline...(PRWeb November 17, 2017)Read the full story at http://www.prweb.com/releases/2017/11/prweb14931818.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - November 17, 2017 Category: Pharmaceuticals Source Type: news

Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 16, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS
CAMBRIDGE, Mass., Nov. 15, 2017 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), focused on developing and commercializing drugs to treat patients with serious cardiometabolic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 15, 2017 Category: Drugs & Pharmacology Source Type: news

Theravance Biopharma and Mylan Submit NDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Nov. 13, 2017 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ( " Theravance Biopharma " ) and Mylan N.V. (NASDAQ, TASE: MYL) ( " Mylan " ) today announced the submission of a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 13, 2017 Category: Drugs & Pharmacology Source Type: news

Theravance Biopharma and Mylan Submit New Drug Application to FDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Filing Supported by Positive Results from Two Pivotal Phase 3 Efficacy Studies and One 12-Month Phase 3 Safety Study DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Nov. 13, 2017 -- (Healthcare Sales & Marketing Network) -- Theravance Biopharma, Inc.... Biopharmaceuticals, FDA Theravance Biopharma, Mylan, Revefenacin, Chronic Obstructive Pulmonary Disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 13, 2017 Category: Pharmaceuticals Source Type: news

Allergan Receives FDA Approval for Vraylar (cariprazine) in the Maintenance Treatment of Schizophrenia
DUBLIN, Nov. 13, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 13, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) November 10, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 10, 2017 Category: Drugs & Pharmacology Source Type: news

FDA approves Roche ’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
Roche today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa ® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. (Source: Roche Media News)
Source: Roche Media News - November 7, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
Roche today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa ® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. (Source: Roche Investor Update)
Source: Roche Investor Update - November 7, 2017 Category: Pharmaceuticals Source Type: news

FDA conducts pre-approval inspection for Intersect ENT ’ s Menlo Park facility
Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 decision date set by the FDA for Sinuva. Get the full story at our sister site, Drug Delivery Business News. The post FDA conducts pre-approval inspection for Intersect ENT’s Menlo Park facility appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Implants Otolaryngology Ear, Nose & Throat Wall Street Beat intersectent Source Type: news

FDA Approves Alecensa (alectinib) as First-Line Treatment for ALK-Positive Metastatic Non-Small Cell Lung Cancer
South San Francisco, CA -- November 6, 2017 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 6, 2017 Category: Drugs & Pharmacology Source Type: news

Progenics Pharmaceuticals Completes Submission of NDA for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma
NEW YORK, Nov. 02, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, announced today that it has completed the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2017 Category: Drugs & Pharmacology Source Type: news

Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-118, Novel Plaque Psoriasis Treatment
LAVAL, Quebec, Nov. 2, 2017 /PRNewswire/ -- Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2017 Category: Drugs & Pharmacology Source Type: news

Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection)
November 2, 2017 -- Trevena, Inc. (NASDAQ:TRVN) today announced that it has recently submitted its New Drug Application (NDA) for Olinvo (oliceridine injection) to the U.S. Food and Drug Administration (FDA). Olinvo is the first G protein biased... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2017 Category: Drugs & Pharmacology Source Type: news

Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Princeton, N.J. —November 1, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committees Recommend Approval of Indivior ’s RBP-6000 for the Treatment of Opioid Use Disorder
Slough, UK and Richmond, VA, 31 October 2017 – Indivior PLC (LON: INDV) announced today that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2017 Category: Drugs & Pharmacology Source Type: news

GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling NDA Submission to U.S. FDA for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome
LONDON and CARLSBAD, Calif., Oct. 30, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ( " GW " or " the Company " ), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 30, 2017 Category: Drugs & Pharmacology Source Type: news

AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
NORTH CHICAGO, Ill., Oct. 27, 2017 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2017 Category: Drugs & Pharmacology Source Type: news

Achaogen Submits Plazomicin New Drug Application (NDA) to the U.S. FDA for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
SOUTH SAN FRANCISCO, Calif., Oct. 26, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 26, 2017 Category: Drugs & Pharmacology Source Type: news

PTC Therapeutics Receives Complete Response Letter for Ataluren's NDA
SOUTH PLAINFIELD, N.J., Oct. 25, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Office of Drug Evaluation I of the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 25, 2017 Category: Drugs & Pharmacology Source Type: news

Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)
WALTHAM, Mass.--(BUSINESS WIRE)--Oct. 25, 2017-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Inveltys (KPI-121 1%), a topical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 25, 2017 Category: Drugs & Pharmacology Source Type: news

Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. Get the full story at our sister site, Drug Delivery Business News. The post Cerveau inks licensing deal with AbbVie for tau imaging agent appeared fir...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Imaging Pharmaceuticals Wall Street Beat AbbVie Cerveau Technologies Source Type: news

FDA Rejects Testosterone Autoinjector Xyosted FDA Rejects Testosterone Autoinjector Xyosted
The US FDA has issued a complete response letter indicating that it cannot approve the new drug application for the weekly subcutaneously self-administered testosterone because of two clinical concerns.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 23, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

FDA pushing back safety compliance deadlines for agricultural water standards because they are "complicated" and "costly"
(Natural News) When it comes to granting its blessing for substances to be legally marketed as preventing or curing disease, the U.S. Food and Drug Administration (FDA) seems to have no problem extorting upwards of several million dollars per substance in “New Drug Application” (NDA) fees from companies who wish to buy the government’s permission... (Source: NaturalNews.com)
Source: NaturalNews.com - October 23, 2017 Category: Consumer Health News Source Type: news

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