FDA Grants Priority Review to Genentech ’s Personalized Medicine Entrectinib
South San Francisco, CA -- February 18, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 18, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
TITUSVILLE, N.J., February 12, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 12, 2019 Category: Drugs & Pharmacology Source Type: news

Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome
EMERYVILLE, Calif., Feb. 06, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 6, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Daiichi Sankyo ’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
Tokyo, Munich and Basking Ridge, NJ– February 5, 2019– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 5, 2019 Category: Drugs & Pharmacology Source Type: news

Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy
AUSTIN, Texas, Feb. 05, 2019 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a clinical-stage drug development company, today announced feedback from a meeting held January 31, 2019 with the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 5, 2019 Category: Drugs & Pharmacology Source Type: news

SK Life Science Announces FDA Acceptance of NDA Submission for Cenobamate, an Investigational Antiepileptic Drug
FAIR LAWN, N.J., Feb. 4, 2019 /PRNewswire/ -- SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative biopharmaceutical company focused on developing and bringing to market treatments for central nervous system (CNS)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 4, 2019 Category: Drugs & Pharmacology Source Type: news

Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
DUBLIN, Feb. 1, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 1, 2019 Category: Drugs & Pharmacology Source Type: news

Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)
MARLBOROUGH, Mass.--(BUSINESS WIRE) January 30, 2019 --Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 30, 2019 Category: Drugs & Pharmacology Source Type: news

Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
THOUSAND OAKS, Calif. and BRUSSELS, Jan. 16, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 21, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
PARIS and THE WOODLANDS, TX– January 17, 2019– The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 17, 2019 Category: Drugs & Pharmacology Source Type: news

New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
TOKYO and STAMFORD, Conn.– January 15, 2019– Eisai Co., Ltd. (CEO: Haruo Naito,“Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD,“Purdue Pharma”) today announced that a new drug application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 15, 2019 Category: Drugs & Pharmacology Source Type: news

US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
January 14, 2019 - Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 14, 2019 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA
DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
SAN DIEGO, Dec. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 31, 2018 Category: Drugs & Pharmacology Source Type: news

Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration
WALTHAM, Mass.--(BUSINESS WIRE)--Dec. 26, 2018-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY™ mucus-penetrating particle... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 26, 2018 Category: Drugs & Pharmacology Source Type: news

Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.— December 23, 2018— Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of Brixadi (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2018 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
DUBLIN, Dec. 21, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4 –17
BRISBANE, Calif.--(BUSINESS WIRE)--Dec. 21, 2018-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it has submitted a Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Pharmaxis Announces Resubmission of Bronchitol NDA
Sydney, Australia -- December 20, 2018 -- Pharmaceutical research company Pharmaxis (ASX: PXS) today announced the resubmission of the Bronchitol New Drug Application with the United States Food and Drug Administration (FDA) by its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark
Research Triangle Park, NC, December 20, 2018– Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, following a pre-submission meeting with the oncology division of the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis
NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
DUBLIN, Ireland, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
CAMBRIDGE, Mass., Dec. 20, 2018 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, announced today that it has completed the submission of its rolling New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Assertio Therapeutics Announces Submission of NDA for FDA Approval of Cosyntropin Depot
LAKE FOREST, Ill., Dec. 20, 2018 (GLOBE NEWSWIRE) -- Assertio Therapeutics, Inc. (NASDAQ: ASRT) today announced that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for its novel injectable formulation of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

DBV Technologies Provides Update on Viaskin Peanut for Children Four to 11 Years of Age - BLA Withdrawn
December 19, 2018 -- DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Clearside Biomedical Submits New Drug Application for Xipere for the Treatment of Macular Edema Associated with Uveitis
ALPHARETTA, Ga., Dec. 19, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
DUBLIN and CAMBRIDGE, Mass., Dec. 17, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 17, 2018 Category: Drugs & Pharmacology Source Type: news

UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer
NEW YORK--(BUSINESS WIRE)--Dec. 17, 2018-- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced that it has initiated the rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 17, 2018 Category: Drugs & Pharmacology Source Type: news

Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration
THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE®... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 17, 2018 Category: Drugs & Pharmacology Source Type: news

Intra-Cellular Therapies Announces FDA Acceptance of New Drug Application for Lumateperone for the Treatment of Schizophrenia
NEW YORK, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 11, 2018 Category: Drugs & Pharmacology Source Type: news

Pfenex Submits New Drug Application to U.S. FDA Seeking Approval of PF708 for the Treatment of Osteoporosis
SAN DIEGO, December 10, 2018-- Pfenex Inc. (NYSE American: PFNX) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of PF708 for the treatment of osteoporosis. The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 10, 2018 Category: Drugs & Pharmacology Source Type: news

New Barhemsys PDUFA Date Confirmed for 5 May 2019
Cambridge, UK and Indianapolis, US– 7 December 2018: Acacia Pharma Group plc (“Acacia Pharma” or“the Company”), a pharmaceutical company developing and commercialising hospital products for US and international... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis Announces FDA Filing Acceptance and Priority Review of AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1
Basel, December 3, 2018 - Novartis today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for AVXS-101, now known as Zolgensma (onasemnogene abeparvovec-xxxx)[1], an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 3, 2018 Category: Drugs & Pharmacology Source Type: news

Shield Therapeutics Announces the NDA for Feraccru has been Accepted for Filing and Review by FDA
London, UK, 3rd December 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today announces that the US Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis
FLORHAM PARK, New Jersey, November 29, 2018 /PRNewswire/ -- The pharmaceutical multinational Exeltis, with a strong position in Women's Health, has received acceptance from the US Food and Drug Administration (FDA) of the filing of Slinda (4mg... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Daiichi Sankyo ’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Tokyo, Munich and Basking Ridge, NJ– (November 21, 2018)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 21, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 20, 2018-- Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name
IRVINE, Calif., Nov. 19, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced the conditional acceptance from the U.S. Food and Drug Administration (“FDA”) of the Jeuveau™... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 19, 2018 Category: Drugs & Pharmacology Source Type: news

Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018
MAHWAH, N.J., Nov. 15, 2018 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company is presenting new data for for its leading respiratory pipeline candidate Ryaltris (rye - al' - tris)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Merck Begins Rolling Submission of Licensure Application for V920 (rVSV ∆G-ZEBOV-GP) to U.S. Food and Drug Administration
KENILWORTH, N.J.--(BUSINESS WIRE) November 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it has started the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 13, 2018 Category: Drugs & Pharmacology Source Type: news

Karyopharm ’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
NEWTON, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 7, 2018 Category: Drugs & Pharmacology Source Type: news

Acacia Pharma Resubmits Barhemsys New Drug Application
Cambridge, UK and Indianapolis, US– 6 November 2018: Acacia Pharma Group plc (“Acacia Pharma” or“the Company”), a pharmaceutical company developing and commercialising hospital products for US and international... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 6, 2018 Category: Drugs & Pharmacology Source Type: news

Trevena Receives Complete Response Letter for Oliceridine from FDA
November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine.“While we... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2018 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections
DUBLIN, Ireland, Nov. 01, 2018 (GLOBE NEWSWIRE) --  Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 1, 2018 Category: Drugs & Pharmacology Source Type: news

Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 1, 2018 Category: Drugs & Pharmacology Source Type: news

Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate
BRIDGEWATER, N.J., Oct. 30, 2018 /PRNewswire/ -- The United States Food and Drug Administration (FDA) has accepted a Biologics License Application for Sanofi Pasteur's dengue vaccine. The dengue vaccine candidate has been granted priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 30, 2018 Category: Drugs & Pharmacology Source Type: news