PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
Prescription Drug User Fee Act (PDUFA) date set for August 16, 2020. MADRID and DUBLIN, Feb. 17, 2020 -- (Healthcare Sales & Marketing Network) -- PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Admi... Biopharmaceuticals, Oncology, FDA Jazz Pharmaceuticals, PharmaMar , lurbinectedin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 17, 2020 Category: Pharmaceuticals Source Type: news

FDA Grants Priority Review to Tucatinib for HER2-Positive Breast Cancer Treatment
The FDA granted a priority review to a new drug application submitted by Seattle Genetics, Inc. for tucatinib to treat patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - February 14, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

FDA Grants Priority Review to Ripretinib for Advanced Gastrointestinal Stromal Tumors
The FDA granted a priority review to Deciphera Pharmaceuticals ’ new drug application for ripretinib to treat patients with advanced gastrointestinal stromal tumors. (Source: CancerNetwork)
Source: CancerNetwork - February 13, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb ’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) February 13, 2020 --Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2020 Category: Drugs & Pharmacology Source Type: news

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC)(1). (Source: World Pharma News)
Source: World Pharma News - February 12, 2020 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

This drug maker's kidney disease treatment scores $50M payday
FibroGen Inc. will receive $50 million from partner AstraZeneca after federal regulators accepted the San Francisco company's application to approve a drug for treating anemia in chronic kidney disease patients. Acceptance of FibroGen's new drug application for the drug, called roxadustat, by the Food and Drug Administration means AstraZeneca plc (NYSE: AZN) must pay $50 million to FibroGen, the company said in a Securities and Exchange Commission filing Tuesday. Roxadustat, an oral small-molecule… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 12, 2020 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

This drug maker's kidney disease treatment scores $50M payday
FibroGen Inc. will receive $50 million from partner AstraZeneca after federal regulators accepted the San Francisco company's application to approve a drug for treating anemia in chronic kidney disease patients. Acceptance of FibroGen's new drug application for the drug, called roxadustat, by the Food and Drug Administration means AstraZeneca plc (NYSE: AZN) must pay $50 million to FibroGen, the company said in a Securities and Exchange Commission filing Tuesday. Roxadustat, an oral small-molecule… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 12, 2020 Category: Biotechnology Authors: Ron Leuty Source Type: news

Trevena again asks FDA to approve its experimental opioid pain reliever
Trevena Inc. said Monday it has resubmitted its new drug application for IV oliceridine, an opioid pain relief medicine designed to have fewer side affects than traditional opioids, to the Food and Drug Administration. The FDA in late 2018 rejected the Chester County biopharmaceutical company's application for oliceridine, which has the proposed brand name Olinvo, as a treatment for moderate-to-severe pain for patients while they are in the hospital. Trevena (NASDAQ: TRVN) conducted additional… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 10, 2020 Category: Biotechnology Authors: John George Source Type: news

Trevena resubmits a new drug application for its experimental opioid
Trevena Inc. said Monday it has resubmitted its new drug application for IV oliceridine, an opioid pain relief medicine designed to have fewer side affects than traditional opioids, to the Food and Drug Administration. The FDA in late 2018 rejected the Chester County biopharmaceutical company's application for oliceridine, which has the proposed brand name Olinvo, as a treatment for moderate-to-severe pain for patients while they are in the hospital. Trevena (NASDAQ: TRVN) conducted additional… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 10, 2020 Category: Biotechnology Authors: John George Source Type: news

Strides to acquire 18 abbreviated new drug applications from Pharmaceutics International, Inc
Strides will significantly expand its niche offerings on its front-end, which has grown multi-fold to attain a quarterly revenue size of USD 66 million. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 7, 2020 Category: Pharmaceuticals Source Type: news

FDA clears investigational new drug application for Calibr's 'switchable' CAR-T therapy
(Scripps Research Institute) Calibr, the drug discovery and development division of Scripps Research, today announced that the US Food and Drug Administration has given clearance to the Investigational New Drug (IND) application for Calibr's 'switchable' CAR-T cell therapy, which is being evaluated for the treatment of certain cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 3, 2020 Category: International Medicine & Public Health Source Type: news

Roche announces CHMP recommendation for EU approval of Venclyxto plus Gazyvaro for people with untreated chronic lymphocytic leukaemia
Basel, 31 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).“Despite advances in treating chronic lymphocytic leukaemia, many patients cannot tolerate the side effects of chemotherapy-containing regimens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product ...
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news

FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health
Today, the U.S. Food and Drug Administration is making critical updates to our policy for prioritizing the review of abbreviated new drug applications (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
INDIANAPOLIS, Jan. 29, 2020 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (L... Biopharmaceuticals, Oncology, FDA Eli Lilly, selpercatinib, RET-mutant, thyroid cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 29, 2020 Category: Pharmaceuticals Source Type: news

Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
INDIANAPOLIS, Jan. 29, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 29, 2020 Category: Drugs & Pharmacology Source Type: news

Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, Jan. 28, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review of Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma
Issued: London, UK -- GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) granted a priority review for the company’s Biologics License Application (BLA) seeking approval of belantamab mafodotin (GSK2857916)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older
KENILWORTH, N.J.--(BUSINESS WIRE)-- Monday, January 27, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Dificid... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for Adlarity (donepezil transdermal system) for the Treatment of Alzheimer ’s Disease
MENLO PARK, Calif., January 27, 2020 (GLOBE NEWSWIRE)– Corium, Inc., a commercial-stage biopharmaceutical company leading the development of novel transdermal healthcare products that are intended to provide alternative treatment options for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

Liquidia Submits New Drug Application for LIQ861 (treprostinil) Inhalation Powder to FDA for the Treatment of Pulmonary Arterial Hypertension (PAH)
RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development of products using its proprietary... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – Jan. 2020
The FDA offers priority review to abbreviated new drug applications (ANDAs) that may have meaningful impact on generic drug access. Priority review means that FDA gives an ANDA submission either (1) a shorter goal date, or (2) an expedited review. For an ANDA submission to be eligible for priority r (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
Assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to 19 support marketing approval of drugs and biological products2 for the treatment of specific 20 hematologic malignancies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Competitive Generic Therapy Approvals
A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
DUBLIN, Jan. 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration on January 21, 2020 seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 22, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Evoke Pharma ’s NDA Resubmission for Gimoti
SOLANA BEACH, Calif., Jan. 21, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on the development of drugs to treat gastrointestinal (GI) disorders and diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

ICYMI: 2019 brings innovative medicines to patients
New reports from the U.S. Food and Drug Administration (FDA) show a total of 56 novel new medicines were approved in 2019. Among these,48 were approved by the Center for Drug Evaluation and Research (CDER) and 8 were approved by the Center for Biologics Evaluation and Research (CBER). While medicine approval numbers vary each year, 2019 saw exciting advancements in drug development. These strong approval figures demonstrate biopharmaceutical companies ’ unwavering commitment to developing innovative treatments for patients, offering hope for improved health outcomes. 2019 also highlights continued success of thePresc...
Source: The Catalyst - January 17, 2020 Category: Pharmaceuticals Tags: Research and Development FDA PDUFA New Era of Medicine & D Focus Source Type: news

ANI Pharmaceuticals Announces FDA Approval of Potassium Citrate Extended-Release Tablets USP
BAUDETTE, Minn., Jan. 16, 2020 -- (Healthcare Sales & Marketing Network) -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and... Biopharmaceuticals, Generics, FDA ANI Pharmaceuticals, Potassium Citrate (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 16, 2020 Category: Pharmaceuticals Source Type: news

Intellipharmaceutics Provides Update on FDA Advisory Committees Meeting for Aximris XR (Oxycodone Hydrochloride extended release) an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
TORONTO, ON / ACCESSWIRE / January 16, 2020 / Intellipharmaceutics International Inc. (OTCQB:IPCIF and TSX:IPCI) ( " Intellipharmaceutics " or the " Company " ), a pharmaceutical company specializing in the research, development and manufacture of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 16, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma
NEW YORK, Jan. 16, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, announced that the Company has initiated a rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 16, 2020 Category: Drugs & Pharmacology Source Type: news

Lynparza regulatory submission granted Priority Review in the US for 1st-line maintenance treatment with bevacizumab in advanced ovarian cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab. (Source: World Pharma News)
Source: World Pharma News - January 15, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity
"The company has received final approval from the US Food& Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 15, 2020 Category: Pharmaceuticals Source Type: news

Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol
SAN FRANCISCO, Jan. 14, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) issued a statement today following a meeting of the Food and Drug Administration's (FDA's) Anesthetic and Analgesic Drug Products... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 14, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 13, 2020 Category: Drugs & Pharmacology Source Type: news

Chiasma Announces FDA Acceptance of Mycapssa New Drug Application Resubmission
NEEDHAM, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 13, 2020 Category: Drugs & Pharmacology Source Type: news

Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 10, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company has initiated a rolling submission of its New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 10, 2020 Category: Drugs & Pharmacology Source Type: news

Top-Line Data Reported for Pralsetinib in Patients with RET Fusion-Positive NSCLC
Data from the ongoing phase I/II ARROW clinical trial will be used to support a new drug application submission for pralsetinib to the FDA for the treatment of patients with RET fusion-positive non-small cell lung cancer. (Source: CancerNetwork)
Source: CancerNetwork - January 10, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ -- Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection) in support of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous Contepo (fosfomycin) for Injection
DUBLIN, Ireland, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction
AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). (Source: World Pharma News)
Source: World Pharma News - January 6, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA
Planegg/Munich, Germany, December 30, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX& TecDAX; NASDAQ: MOR) announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 30, 2019 Category: Drugs & Pharmacology Source Type: news

Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dec. 30, 2019-- Urovant Sciences (Nasdaq: UROV) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 30, 2019 Category: Drugs & Pharmacology Source Type: news

Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer
Morris Plains, N.J., Dec. 26, 2019 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the“Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 26, 2019 Category: Drugs & Pharmacology Source Type: news

Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
VANCOUVER, Dec. 24, 2019 /PRNewswire/ - Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced it has received a Complete Response Letter... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 24, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
December 23, 2019 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito,“Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

Lannett Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules
PHILADELPHIA, Dec. 23, 2019 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for... Biopharmaceuticals, Generics, FDA Lannett Company (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 23, 2019 Category: Pharmaceuticals Source Type: news

Zosano Announces FDA Submission of New Drug Application for Qtrypta
FREMONT, Calif., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced the submission of a 505(b)(2) New Drug Application (“NDA”) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease
SAN FRANCISCO, Dec. 23, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roxadustat for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
BOTHELL, Wash.--(BUSINESS WIRE) December 23, 2019 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2019 Category: Drugs & Pharmacology Source Type: news