Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019
SALT LAKE CITY, May 14, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 14, 2019 Category: Drugs & Pharmacology Source Type: news

RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
TEL-AVIV, Israel and RALEIGH, N.C., May 7, 2019 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the“Company”), a specialty biopharmaceutical company primarily focused on... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 7, 2019 Category: Drugs & Pharmacology Source Type: news

Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)
Devon, PA, May 6, 2019— Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 6, 2019 Category: Drugs & Pharmacology Source Type: news

Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
ANN ARBOR, Mich., May 05, 2019 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 5, 2019 Category: Drugs & Pharmacology Source Type: news

Complete Response Letter from FDA for Barhemsys
Cambridge, UK and Indianapolis, US– 3 May 2019: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2019 Category: Drugs & Pharmacology Source Type: news

Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain
SAN DIEGO, May 1, 2019 /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 - May 1, 2019 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous Contepo (fosfomycin) for injection
DUBLIN, Ireland, April 30, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 30, 2019 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
WHIPPANY, N.J., April 29, 2019 /PRNewswire/ -- Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 30, 2019 Category: Drugs & Pharmacology Source Type: news

Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV
Cork,Ireland, April 29, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson have announced that a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) has been submitted by ViiV Healthcare for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 30, 2019 Category: Drugs & Pharmacology Source Type: news

Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
Basel, April 15, 2019 - Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 15, 2019 Category: Drugs & Pharmacology Source Type: news

Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
Dublin– April 9, 2019– Cosmo Pharmaceuticals NV (SIX: COPN) today informed that the Remimazolam NDA has been submitted to FDA. Electronic acknowledgment of the submission shows April 5 as the official date of submission. Therefore... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 9, 2019 Category: Drugs & Pharmacology Source Type: news

Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
EMERYVILLE, Calif., April 08, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 8, 2019 Category: Drugs & Pharmacology Source Type: news

Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
SUMMIT, N.J.& CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2019 -- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 5, 2019 Category: Drugs & Pharmacology Source Type: news

Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
TOKYO--(BUSINESS WIRE)--Apr 4, 2019--Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi Miyamoto,“Kyowa Kirin”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 4, 2019 Category: Drugs & Pharmacology Source Type: news

Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA
SOLANA BEACH, Calif., April 02, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has received a Complete Response Letter... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 3, 2019 Category: Drugs & Pharmacology Source Type: news

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
SUMMIT, N.J.--(BUSINESS WIRE)--March 25, 2019 Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
PARIS and THE WOODLANDS, TX–  March 22, 2019 -  The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2019 Category: Drugs & Pharmacology Source Type: news

Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
SOLANA BEACH, Calif., March 14, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has submitted its response to the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 14, 2019 Category: Drugs & Pharmacology Source Type: news

Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
NEWTON, Mass., March 14, 2019 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 14, 2019 Category: Drugs & Pharmacology Source Type: news

Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
TOKYO and STAMFORD, Conn.– March 12, 2019– Eisai Co., Ltd. (CEO: Haruo Naito,“Eisai”) and Imbrium Therapeutics L.P. (Imbrium Therapeutics), a clinical-stage biopharmaceutical company and operating subsidiary of Purdue... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 12, 2019 Category: Drugs & Pharmacology Source Type: news

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
DUBLIN, March 11, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 12, 2019 Category: Drugs & Pharmacology Source Type: news

TB Medicine Pretomanid Enters Regulatory Review Process in the United States
NEW YORK, NY (March 8, 2019)—TB Alliance’s new drug application (NDA) for the novel tuberculosis (TB) drug candidate pretomanid has been accepted for review by the United States Food and Drug Administration (FDA). The application is for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 9, 2019 Category: Drugs & Pharmacology Source Type: news

Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne
REHOVOT, Israel, and BRIDGEWATER, N.J., March 07, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 7, 2019 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis
SUMMIT, N.J.--(BUSINESS WIRE)-- March 05, 2019 - Celgene Corporation (NASDAQ:CELG) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fedratinib and granted a Priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 5, 2019 Category: Drugs & Pharmacology Source Type: news

Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER
TORONTO, ON / ACCESSWIRE / March 4, 2019 / Intellipharmaceutics International Inc. (NASDAQ: IPCI, TSX: IPCI) ("Intellipharmaceutics" or the"Company"), a pharmaceutical company specializing in the research, development and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 4, 2019 Category: Drugs & Pharmacology Source Type: news

Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
WHIPPANY, N.J., Feb. 27, 2019 /PRNewswire/ -- Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide. The submission,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2019 Category: Drugs & Pharmacology Source Type: news

Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma
NEWTON, Mass., Feb. 26, 2019 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2019 Category: Drugs & Pharmacology Source Type: news

Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis
DUBLIN, Ireland and CAMBRIDGE, Mass., Feb. 25, 2019 (GLOBE NEWSWIRE) -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 25, 2019 Category: Drugs & Pharmacology Source Type: news

AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2019 Category: Drugs & Pharmacology Source Type: news

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

Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
CAMBRIDGE, Mass., Feb. 14, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced the Food and Drug Administration, Division of Neurology (the Division), has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 14, 2019 Category: Drugs & Pharmacology Source Type: news

Motif Bio Receives Complete Response Letter From The FDA
NEW YORK, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the Company has received a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 14, 2019 Category: Drugs & Pharmacology Source Type: news

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant
PLYMOUTH MEETING, PA, February 12, 2019— Harmony Biosciences, LLC (Harmony), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 12, 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