Dynavax Provides Regulatory Update on Heplisav-B
BERKELEY, CA -- (Marketwired) -- 09/04/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 4, 2016 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017
DUBLIN, Oct. 3, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq; JAZZ) today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) on September 30, 2016,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 3, 2016 Category: Drugs & Pharmacology Source Type: news

Pain Therapeutics Receives Complete Response Letter for Remoxy ER
AUSTIN, Texas, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 27, 2016 Category: Drugs & Pharmacology Source Type: news

Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
Paris, France, and Tarrytown, N.Y. - September 26, 2016 - Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 26, 2016 Category: Drugs & Pharmacology Source Type: news

Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 26, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 26, 2016 Category: Drugs & Pharmacology Source Type: news

Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy
CAMBRIDGE, Mass.& CARLSBAD, Calif.--(BUSINESS WIRE) September 26, 2016 --Biogen (NASDAQ: BIIB) and Ionis (NASDAQ:IONS) today announced that Biogen has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 26, 2016 Category: Drugs & Pharmacology Source Type: news

Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis
HORSHAM, Pa.--(BUSINESS WIRE) September 23, 2016 --Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) seeking approval of sirukumab... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 24, 2016 Category: Drugs & Pharmacology Source Type: news

Newron Re-Submits US NDA for Xadago (safinamide)
MILAN--(BUSINESS WIRE) September 22, 2016 --Newron Pharmaceuticals S.p.A. ( “Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2016 Category: Drugs & Pharmacology Source Type: news

Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
LOS ANGELES, Calif., Sept. 20, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 20, 2016 Category: Drugs & Pharmacology Source Type: news

TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)
BOCA RATON, Fla.--(BUSINESS WIRE)--Sep. 19, 2016-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women ’s healthcare company, today announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 19, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
The Woodlands, Texas, September 14, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (“FDA”) will require additional time to complete its review of the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 14, 2016 Category: Drugs & Pharmacology Source Type: news

Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Tesaro, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2016 Category: Drugs & Pharmacology Source Type: news

Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%
IRVINE, Calif.--(BUSINESS WIRE) September 6, 2016 -- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 6, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Extends Regulatory Review Period for IDegLira by Three Months
Bagsv ærd, Denmark, 2 September 2016 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in adults with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 2, 2016 Category: Drugs & Pharmacology Source Type: news

Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma
BOULDER, Colo., Sept. 1, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced that the FDA has accepted its New Drug Application (NDA) for binimetinib with a target action date under the Prescription Drug User Fee Act (PDUFA) of June... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2016 Category: Drugs & Pharmacology Source Type: news

Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment
NESS ZIONA, Israel/Fort Lee, NJ -- September 1, 2016 – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications and Kedrion S.p.A., the parent company of Kedrion Biopharma Inc., a company... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2016 Category: Drugs & Pharmacology Source Type: news

ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 30, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2016 Category: Drugs & Pharmacology Source Type: news

Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine
SAN DIEGO, Aug. 31, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Ingrezza for the Company's once-daily vesicular... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 31, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Mitsubishi Tanabe Pharma's NDA Filing for Edaravone to Treat ALS
OSAKA, Japan, Aug. 30, 2016 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President& Representative Director, CEO: Masayuki Mitsuka), today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 30, 2016 Category: Drugs & Pharmacology Source Type: news

Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia
SAN DIEGO, Aug. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 29, 2016 Category: Drugs & Pharmacology Source Type: news

Amgen Provides Update on Status of Parsabiv (Etelcalcetide) NDA Submitted to the U.S. FDA
THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv (etelcalcetide) for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Clovis Oncology ’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Aug. 23, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Clovis ’ New Drug Application (NDA) for accelerated approval of rucaparib and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 24, 2016 Category: Drugs & Pharmacology Source Type: news

Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes
Copenhagen, 20 August 2016 - Zealand Pharma (Zealand) announced today that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 21, 2016 Category: Drugs & Pharmacology Source Type: news

Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)
SOUTH SAN FRANCISCO, Calif., Aug. 17, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc. ® (NASDAQ:PTLA) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 18, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome
Princeton, NJ – August 18, 2016 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 18, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Marathon Pharmaceuticals ’ NDA for Deflazacort for the Treatment of Duchenne Muscular Dystrophy
Northbrook, Ill. – August 10, 2016 – Marathon Pharmaceuticals, LLC, a biopharmaceutical company developing treatments for rare diseases, today announced the New Drug Applications (NDA) for the investigational drug deflazacort have been accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2016 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease
August 8, 2016 - Pfizer Inc. (NYSE:PFE) announced the publication of a new post-hoc analysis of data from three studies of Vyndaqel in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 8, 2016 Category: Drugs & Pharmacology Source Type: news

Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
KENILWORTH, N.J.--(BUSINESS WIRE), August 5, 2016 --Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 5, 2016 Category: Drugs & Pharmacology Source Type: news

Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate)
WAYNE, Pa., Aug. 4, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ( " Egalet " ), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 4, 2016 Category: Drugs & Pharmacology Source Type: news

Newron to Re-Submit US NDA for Xadago (safinamide)
MILAN--(BUSINESS WIRE) July 26, 2016 --Newron Pharmaceuticals S.p.A. ( “Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 26, 2016 Category: Drugs & Pharmacology Source Type: news

Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 25, 2016-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 25, 2016 Category: Drugs & Pharmacology Source Type: news

Valeant Pharmaceuticals Receives FDA Complete Response Letter for Latanoprostene Bunod
LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 22, 2016 Category: Drugs & Pharmacology Source Type: news

Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
LOS ANGELES, Calif., July 21, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 21, 2016 Category: Drugs & Pharmacology Source Type: news

Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA
THOUSAND OAKS, Calif. and BRUSSELS, July 21, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 21, 2016 Category: Drugs & Pharmacology Source Type: news

Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
KENILWORTH, N.J.--(BUSINESS WIRE) July 21, 2016 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 21, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends Approval Of Brodalumab For Treatment Of Moderate-To-Severe Plaque Psoriasis
LAVAL, Quebec, July 19, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Issues Complete Response Letter For SequestOx New Drug Application
NORTHVALE, N.J., July 15, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ( " Elite " or the " Company " ) (OTCBB:ELTP) today announced that the U.S. Food and Drug Administration (the " FDA " ) has issued a Complete Response Letter (the " CRL " ) regarding... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 15, 2016 Category: Drugs & Pharmacology Source Type: news

Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program
NEW YORK--(BUSINESS WIRE) July 15, 2016 --Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 15, 2016 Category: Drugs & Pharmacology Source Type: news

Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
THOUSAND OAKS, Calif., July 12, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 13, 2016 Category: Drugs & Pharmacology Source Type: news

TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR)
BOCA RATON, Fla.--(BUSINESS WIRE)--Jul. 7, 2016-- TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women ’s healthcare company, announced today that it has submitted its New Drug Application (NDA) for Yuvvexy with the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 7, 2016 Category: Drugs & Pharmacology Source Type: news

Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia
CHAPEL HILL, N.C., July 05, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 5, 2016 Category: Drugs & Pharmacology Source Type: news

Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA
BOULDER, Colo., June 30, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced the submission of a New Drug Application (NDA) for binimetinib in patients with advanced NRAS-mutant melanoma to the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2016 Category: Drugs & Pharmacology Source Type: news

Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA
SALT LAKE CITY, June 29, 2016 (GLOBE NEWSWIRE) -- Lipocine Inc. (LPCN), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (“CRL”) from the United States Food and Drug Administration (“FDA”)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Genentech ’s Ocrevus (ocrelizumab) Biologics License Application
South San Francisco, CA -- June 27, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company ’s Biologics License Application (BLA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 28, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application
South San Francisco, CA -- June 27, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 28, 2016 Category: Drugs & Pharmacology Source Type: news

Roche’s Marketing Applications for Review of Ocrevus (ocrelizumab) in Two Forms of Multiple Sclerosis Accepted by EMA and FDA
Basel, 28 June 2016 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) of Ocrevus (ocrelizumab) for the treatment of relapsing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 28, 2016 Category: Drugs & Pharmacology Source Type: news

Advanced Accelerator Applications Announces FDA Priority Review for Lutathera
SAINT-GENIS-POUILLY, France, June 27, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2016 Category: Drugs & Pharmacology Source Type: news

Medimetriks Pharmaceuticals, Inc. Submits NDA to FDA for Ozenoxacin Cream for Impetigo
FAIRFIELD, N.J., June 27, 2016 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ozenoxacin cream, 1%, a novel,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2016 Category: Drugs & Pharmacology Source Type: news

Mitsubishi Tanabe Pharma Submits New Drug Application for Edaravone to Treat ALS in the United States
OSAKA, Japan, June 20, 2016 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President & Representative Director, CEO: Masayuki Mitsuka), today announced that a New Drug Application has been submitted to the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 22, 2016 Category: Drugs & Pharmacology Source Type: news