FDA approves Jazz Pharmaceutical sleep disorder drug
The Food and Drug Administration approved Jazz Pharmaceutical's new drug application for Sunosi, a once-daily medicine designed to improve wakefulness in adult patients suffering from narcolepsy and obstructive sleep apnea. Sunosi is expected to be commercially available in the United States following the final scheduling decision by the U.S. Drug Enforcement Administration, which is typically rendered within 90 days of FDA approval. Jazz Pharmaceuticals, which is based in Dublin, Ireland,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 21, 2019 Category: Biotechnology Authors: John George Source Type: news

FDA approves Jazz Pharmaceutical sleep disorder drug
The Food and Drug Administration approved Jazz Pharmaceutical's new drug application for Sunosi, a once-daily medicine designed to improve wakefulness in adult patients suffering from narcolepsy and obstructive sleep apnea. Sunosi is expected to be commercially available in the United States following the final scheduling decision by the U.S. Drug Enforcement Administration, which is typically rendered within 90 days of FDA approval. Jazz Pharmaceuticals, which is based in Dublin, Ireland,… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - March 21, 2019 Category: American Health Authors: John George Source Type: news

FDA decision on Jazz Pharmaceuticals narcolepsy drug expected Wednesday
The Food and Drug Administration is expected to make a decision by Wednesday on a new drug application filed by Jazz Pharmaceuticals for its experimental narcolepsy drug solriamfetol. The FDA was originally set to make a ruling on the application in late December, but its review was extended by three months after the federal agency determined an submission made by Jazz during discussions regarding draft labeling for solriamfetol constituted a "major amendment" to its applicatio n. That resulted in… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 19, 2019 Category: Pharmaceuticals Authors: John George 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

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 11, 2019 -- (Healthcare Sales & Marketing Network) -- Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharm... Biopharmaceuticals, FDA Eisai, Imbrium Therapeutics, Lemborexant, Insomnia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 11, 2019 Category: Pharmaceuticals Source Type: news

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Ubrogepant Seeks to be the First Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for the Acute Treatment of Migraine Allergan Continues to Expand Its Leading Migraine Portfolio Across the Spectrum of the Disease from Episodic to Chronic ... Biopharmaceuticals, FDA Allergan, Ubrogepant, Migraine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 11, 2019 Category: Pharmaceuticals 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

TB medicine pretomanid enters regulatory review process in the United States
(Burness) 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). (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - March 8, 2019 Category: Infectious Diseases Source Type: news

Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions
Roche today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta ® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. (Source: Roche Media News)
Source: Roche Media News - March 7, 2019 Category: Pharmaceuticals Source Type: news

Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions
Roche today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta ® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. (Source: Roche Investor Update)
Source: Roche Investor Update - March 7, 2019 Category: Pharmaceuticals 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

FDA accepts Roche ’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications
Roche today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xofluza ™ (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. (Source: Roche Investor Update)
Source: Roche Investor Update - March 6, 2019 Category: Pharmaceuticals 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

Breckenridge Announces Final Approval of its ANDA for Exemestane Tablets (Aromasin(R))
BOCA RATON, Fla., Feb. 27, 2019 -- (Healthcare Sales & Marketing Network) -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Exemestane Ta... Biopharmaceuticals, Generics, Oncology, FDA Breckenridge Pharmaceutical, Exemestane, Aromasin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 27, 2019 Category: Pharmaceuticals 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

FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for IV Push
SAN DIEGO, Feb. 26, 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 Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2019 Category: Drugs & Pharmacology Source Type: news

February 22, 2019: Lehigh Valley Technologies, Inc. to Pay $4 Million to Resolve False Claims Act Liability for Scheme to Avoid FDA New Drug Application Fee
(Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - February 25, 2019 Category: Medical Law 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

Do You Know What ’ s In Your Sunscreen? FDA Proposes New Regulations
By Dr. Edith Bracho-Sanchez, CNN (CNN) — The US Food and Drug Administration is proposing new regulations on over-the-counter sunscreens in an effort to keep up with the latest scientific and safety information. The proposal, announced Thursday, is available for public review and comment for the next 90 days and addresses the safety of common sunscreen ingredients, as well their dosage forms, sun protection factor (SPF) and broad-spectrum requirements. It also addresses labeling, aiming to make it easier for consumers to identify key product information. “Since the initial evaluation of these products, we know ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 22, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Sunscreen Source Type: news

AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Upadacitinib, an investigational once-daily oral JAK1-selective inhibitor, is being studied for the treatment of adult patients with moderate to severe rheumatoid arthritis[1-8] The New Drug Application (NDA) is supported by data from the global upadaci... Biopharmaceuticals, FDA AbbVie, Upadacitinib, Rheumatoid Arthritis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 19, 2019 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s personalised medicine entrectinib
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - February 19, 2019 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s personalised medicine entrectinib
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). (Source: Roche Investor Update)
Source: Roche Investor Update - February 19, 2019 Category: Pharmaceuticals 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

How CEO Stonehouse is building up BioCryst's war chest to finance trials, drug launch
BioCryst pharmaceutical has extended an existing loan agreement to $100 million, hoping to extend its runway and finance through upcoming clinical trials and a new drug application, (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - February 6, 2019 Category: American Health Authors: Seth Thomas Gulledge 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

Sunovion gets CRL for Parkinson ’s drug
Sunovion Pharma announced that the U.S. FDA issued a Complete Response Letter for the New Drug Application for the drugmaker's apomorphine sublingual film (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 4, 2019 Category: Pharmaceuticals Source Type: news

Sunovion gets CRL for Parkinson ’s treatment
Sunovion Pharma announced that the U.S. FDA issued a Complete Response Letter for the New Drug Application for the drugmaker's apomorphine sublingual film (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 4, 2019 Category: Pharmaceuticals Source Type: news

FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have not worked. Read the whole story on our sister site, Drug Delivery Business News The post FDA rejects Alkermes depression drug NDA appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat alkermes 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

FDA rejects Sunovion ’ s NDA for Parkinson ’ s disease-treating apomorphine sublingual film
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy for Parkinson’s patients experiencing “off” episodes, in which symptoms that are usually controlled by medications resurface. Sunovion said that the FDA “determined it was una...
Source: Mass Device - January 31, 2019 Category: Medical Devices Authors: Fink Densford Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Sunovion Pharmaceuticals Source Type: news

Trevena to sell stock, makes progress on resubmitting new drug application
The Chester County biopharmaceutical expects to initiate a new study for its experimental pain medicine, requested by the FDA, during the first half of this year. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - January 31, 2019 Category: American Health Authors: John George 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

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause
BLAINVILLE, QC, January 29, 2019– Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced today that the FDA has approved its supplemental New Drug Application (sNDA) seeking to add moderate to severe vaginal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 29, 2019 Category: Drugs & Pharmacology Source Type: news

South Jersey pharma firm gets FDA approval for generic skin cream
Teligent Inc., a New Jersey-based specialty generic pharmaceutical company, announced Thursday it has received approval for its abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration. The FDA approved the ANDA for a skin disorder treatment called clobetasol propionate ointment from Teligent, a South Jersey specialty generic pharmaceutical company. The cream is used to treat a variety of skin disorders including eczema and psoriasis and for contact dermatitis caused by… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 24, 2019 Category: Biotechnology Authors: John George 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 Down to 5 Weeks of Funding to Review New Drug Applications
THURSDAY, Jan. 17, 2019 -- Due to the federal government shutdown, the U.S. Food and Drug Administration has only about five weeks of funding left to review new drug applications, according to Commissioner Scott Gottlieb, M.D. To keep reviewing... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 17, 2019 Category: Pharmaceuticals Source Type: news

Critical impacts of the government shutdown on the FDA and clinical research
Rachel Martukovich, Clinical Research Associate for IMARC Research, Inc. The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research.  The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds. FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s rec...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news