U.S. FDA Acknowledges Receipt of Shire ’s New Drug Application for SHP465 for ADHD
Lexington, Mass., USA – January 19, 2017 –– Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 20, 2017 Category: Drugs & Pharmacology Source Type: news

Symbiomix Therapeutics Submits New Drug Application to US FDA for Solosec for the Treatment of BV
Newark, NJ, January 19, 2017 – Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, today announced submission of a new drug application (NDA) for Solosec (secnidazole oral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 19, 2017 Category: Drugs & Pharmacology Source Type: news

Ezra Announces FDA Acceptance of Filing of New Drug Application For EZR-104 for the Treatment of Hypertension and Heart Failure
Little Rock, January 18, 2017 -- Ezra Innovations, LLC (Ezra) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for an investigational drug product, EZR-104, for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 18, 2017 Category: Drugs & Pharmacology Source Type: news

Heron Announces Submission of Cinvanti NDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
SAN DIEGO--(BUSINESS WIRE)--Jan. 12, 2017-- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on developing novel best-in-class treatment solutions to address some of the biggest unmet patient needs, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 16, 2017 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment
INDIANAPOLIS, Jan. 13, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 13, 2017 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 12, 2017 Category: Drugs & Pharmacology Source Type: news

Alcobra Provides Update on Recent FDA Meeting and Path Forward for MDX Clinical Development Program
TEL AVIV, Israel, Jan. 09, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 9, 2017 Category: Drugs & Pharmacology Source Type: news

AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain
REDWOOD CITY, Calif., Jan. 8, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, provided... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2017 Category: Drugs & Pharmacology Source Type: news

Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease
EMERYVILLE, Calif., Jan. 06, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 6, 2017 Category: Drugs & Pharmacology Source Type: news

Neurocrine Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia
SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA), after further review of the Ingrezza (valbenazine) New Drug Application (NDA), has decided to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2017 Category: Drugs & Pharmacology Source Type: news

Ironwood Announces New Drug Application for Duzallo (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 4, 2017-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for Duzallo (fixed-dose combination of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2017 Category: Drugs & Pharmacology Source Type: news

Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs
CHAPEL HILL, N.C., Dec. 29, 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 - December 30, 2016 Category: Drugs & Pharmacology Source Type: news

Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. ® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) accepted Portola's New Drug Application (NDA) granting priority review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2016 Category: Drugs & Pharmacology Source Type: news

Elite Provides Update On SequestOx New Drug Application
NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ( " Elite " or the " Company " ) (OTCBB:ELTP) today announced the Company met with the U.S. Food and Drug Administration (the " FDA " ) on December 21, 2016 for an end-of-review... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 22, 2016 Category: Drugs & Pharmacology Source Type: news

Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera, an Investigational Treatment for Neuroendocrine Tumors
SAINT-GENIS-POUILLY, France, Dec. 21, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) ( “AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that following the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2016 Category: Drugs & Pharmacology Source Type: news

Tesaro Announces Priority Review Designation for Niraparib NDA
WALTHAM, Mass., Dec. 20, 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 Priority Review for the niraparib New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2016 Category: Drugs & Pharmacology Source Type: news

Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD
DALLAS/FORT WORTH, Texas, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Extends Review of Application for Ocrevus (ocrelizumab)
South San Francisco, CA -- December 20, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2016 Category: Drugs & Pharmacology Source Type: news

AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C
NORTH CHICAGO, Ill., Dec. 19, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 19, 2016 Category: Drugs & Pharmacology Source Type: news

AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain
REDWOOD CITY, Calif., Dec. 13, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 13, 2016 Category: Drugs & Pharmacology Source Type: news

Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain
BURLINGTON, Mass., Dec. 12, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead investigational product candidate... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 12, 2016 Category: Drugs & Pharmacology Source Type: news

US FDA Accepts First Biologics License Application for AstraZeneca ’s Durvalumab in Bladder Cancer
December 9, 2016 -- AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 9, 2016 Category: Drugs & Pharmacology Source Type: news

Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
NEW YORK--(BUSINESS WIRE) December 9, 2016 -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced positive top-line results from the first of two pivotal phase 3 clinical trials evaluating the efficacy and safety of plecanatide, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 9, 2016 Category: Drugs & Pharmacology Source Type: news

Catalyst Pharmaceuticals Provides Update on its Clinical Trial for Patients with Congenital Myasthenic Syndromes
CORAL GABLES, Fla., Dec. 08, 2016 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2016 Category: Drugs & Pharmacology Source Type: news

Gilead Submits NDA to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 8, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2016 Category: Drugs & Pharmacology Source Type: news

Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes
PLAINSBORO, N.J., Dec. 5, 2016 /PRNewswire/ -- Novo Nordisk today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 5, 2016 Category: Drugs & Pharmacology Source Type: news

Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia
SAN DIEGO, Nov. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in the New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review
November 29, 2016 - EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE (link is external)) today announced that the US Food and Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2016 Category: Drugs & Pharmacology Source Type: news

Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease
CRANBURY, N.J., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of rare and orphan diseases, announces its planned regulatory pathway to collect additional data to support full... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 28, 2016 Category: Drugs & Pharmacology Source Type: news

Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
TORONTO, Nov. 25, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ( " 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 - November 25, 2016 Category: Drugs & Pharmacology Source Type: news

GSK Files Regulatory Submission in US for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD
London, 21 November 2016 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 21, 2016 Category: Drugs & Pharmacology Source Type: news

Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback
SAN DIEGO, Nov. 18, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has received feedback in response to its previously... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 18, 2016 Category: Drugs & Pharmacology Source Type: news

Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment of ADHD
DALLAS/FORT WORTH, Texas, Nov. 17, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2016 Category: Drugs & Pharmacology Source Type: news

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Qapzola
On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) with respect to the Company’s New Drug Application for Qapzola (apaziquone for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2016 Category: Drugs & Pharmacology Source Type: news

Amgen and Allergan Submit Biosimilar BLA for ABP 215 to U.S. FDA
THOUSAND OAKS, Calif., Nov. 15, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 215, a biosimilar... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 15, 2016 Category: Drugs & Pharmacology Source Type: news

Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B
BERKELEY, CA -- (Marketwired) -- 11/14/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 14, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia
CHAPEL HILL, N.C., Nov. 04, 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 - November 4, 2016 Category: Drugs & Pharmacology Source Type: news

Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer
WALTHAM, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has completed the niraparib rolling New Drug Application (NDA) submission to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 1, 2016 Category: Drugs & Pharmacology Source Type: news

ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 31, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ARIAD ’s investigational oral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2016 Category: Drugs & Pharmacology Source Type: news

Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis
Paris and Tarrytown, N.Y. – October 28, 2016 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 28, 2016 Category: Drugs & Pharmacology Source Type: news

Biogen ’s Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA
CAMBRIDGE, Mass.--(BUSINESS WIRE) October 28, 2016 -- Biogen (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been accepted by the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 28, 2016 Category: Drugs & Pharmacology Source Type: news

Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen
CHARLESTON, S.C.--(BUSINESS WIRE) October 26, 2016 --Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced it has successfully completed patient recruitment for the confirmatory Phase 3 clinical trial of Macrilen... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 26, 2016 Category: Drugs & Pharmacology Source Type: news

Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients
SOUTH SAN FRANCISCO, Calif., Oct. 25, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc. ® (Nasdaq:PTLA) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 25, 2016 Category: Drugs & Pharmacology Source Type: news

Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections
NEW HAVEN, Conn. – October 24, 2016 – Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 25, 2016 Category: Drugs & Pharmacology Source Type: news

US FDA Considers Newron ’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter
MILAN--(BUSINESS WIRE)-- October 21, 2016 -- Newron Pharmaceuticals S.p.A. ( “Newron”) (NWRN.SW), 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 - October 21, 2016 Category: Drugs & Pharmacology Source Type: news

Teva Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease
JERUSALEM--(BUSINESS WIRE)--Oct. 20, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 20, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia
18 October 2016 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 18, 2016 Category: Drugs & Pharmacology Source Type: news

Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER
WAYNE, Pa., Oct. 13, 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 - October 13, 2016 Category: Drugs & Pharmacology Source Type: news

Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA
SAN DIEGO, Oct. 11, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for Ingrezza (valbenazine) for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 11, 2016 Category: Drugs & Pharmacology Source Type: news

Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170
Sophia Antipolis, France, 10 October 2016 -- Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 10, 2016 Category: Drugs & Pharmacology Source Type: news