Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA
SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced the resubmission of the Company’s New Drug Application (“NDA”) to the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 20, 2020 Category: Drugs & Pharmacology Source Type: news

Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies
PALO ALTO, Calif. May 19, 2020— Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 19, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease
PARIS– May 14, 2020 - The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 14, 2020 Category: Drugs & Pharmacology Source Type: news

Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities
BOSTON, May 13, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 14, 2020 Category: Drugs & Pharmacology Source Type: news

Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel)
PRINCETON, N.J.--(BUSINESS WIRE)-- May 6, 2020 Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the biologics license application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 6, 2020 Category: Drugs & Pharmacology Source Type: news

Kala Pharmaceuticals Resubmits New Drug Application for Eysuvis for Dry Eye Disease
WATERTOWN, Mass.--(BUSINESS WIRE)--May 4, 2020-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 4, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb ’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
PRINCETON, N.J.--(BUSINESS WIRE) May 1, 2020 --Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral hypomethylating agent,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 1, 2020 Category: Drugs & Pharmacology Source Type: news

Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
DURHAM, N.C., April 28, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the Company has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 29, 2020 Category: Drugs & Pharmacology Source Type: news

CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
VANCOUVER, Washington, April 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the“Company " ), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 27, 2020 Category: Drugs & Pharmacology Source Type: news

Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 8, 2020 Category: Drugs & Pharmacology Source Type: news

Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- April 07, 2020 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 7, 2020 Category: Drugs & Pharmacology Source Type: news

Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA
NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the“Company” or“Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 1, 2020 Category: Drugs & Pharmacology Source Type: news

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA
March 31, 2020 -- PRINCETON, NJ.& CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2020 Category: Drugs & Pharmacology Source Type: news

AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 31, 2020-- AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib, the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2020 Category: Drugs & Pharmacology Source Type: news

Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis
TITUSVILLE, NEW JERSEY, March 18, 2020– The Janssen Pharmaceutical Companies of Johnson& Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ponesimod for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 18, 2020 Category: Drugs & Pharmacology Source Type: news

Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
BUFFALO, N.Y., March 09, 2020 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 9, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma
NEW YORK, March 05, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib, the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 5, 2020 Category: Drugs & Pharmacology Source Type: news

Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder
IRVINE, Calif.& BASEL, Switzerland--(BUSINESS WIRE) March 5, 2020 -- Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 5, 2020 Category: Drugs & Pharmacology Source Type: news

Zosano Pharma Announces FDA Acceptance of 505(b)(2) New Drug Application for Qtrypta ™ for the Acute Treatment of Migraine
FREMONT, Calif., March 04, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq: ZSAN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 4, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis
Monday, March 2, 2020 - Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2020 Category: Drugs & Pharmacology Source Type: news

Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome
EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Genentech ’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer
South San Francisco, CA -- February 24, 2020 -- 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 Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 24, 2020 Category: Drugs & Pharmacology Source Type: news

Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
SAN DIEGO, Feb. 19, 2020 /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... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

Eton Pharmaceuticals Provides Update on ET-105 Program
DEER PARK, Ill., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today provided an update on its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts BioCryst ’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks
RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
MADRID and DUBLIN, Feb. 17, 2020 /PRNewswire/ -- PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 17, 2020 Category: Drugs & Pharmacology 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

Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
BOTHELL, Wash.--(BUSINESS WIRE) February 13, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2020 Category: Drugs & Pharmacology Source Type: news

Deciphera Pharmaceuticals Announces U.S. Food And Drug Administration Acceptance Of New Drug Application And Priority Review For Ripretinib In Patients With Advanced Gastrointestinal Stromal Tumors
WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 12, 2020-- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today 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 12, 2020 Category: Drugs & Pharmacology Source Type: news

FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease
SAN FRANCISCO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review of its New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 11, 2020 Category: Drugs & Pharmacology Source Type: news

Trevena Resubmits New Drug Application for Oliceridine
CHESTERBROOK, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 10, 2020 Category: Drugs & Pharmacology Source Type: news

NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)
KYOTO, Japan and PARAMUS, NJ: February 7, 2020 - Nippon Shinyaku Co., Ltd. (President, Shigenobu Maekawa) and NS Pharma, Inc. (President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku, announced today that the U.S. Food& Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 7, 2020 Category: Drugs & Pharmacology 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

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

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

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

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

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

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

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

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