FDA New Drug Applications

FDA Biotech News, New Drug Applications, Biotech and Pharmaceutical NDA Filings

Drugs.com - New Drug Applications New drug applications news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis
on October 4, 2021 at 1:10 am
WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent...
Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA
on October 1, 2021 at 11:10 pm
SEATTLE--(BUSINESS WIRE)--Oct. 1, 2021-- Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) notified the company that, as part of FDA’s ongoing review of the company’s...
Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®
on September 28, 2021 at 10:09 pm
SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration ("FDA") has...
Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway
on September 27, 2021 at 5:09 am
TOKYO and CAMBRIDGE, Mass, September 27, 2021 - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos,...
Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency
on September 24, 2021 at 1:09 am
NEW YORK, NY and MIAMI, FL September 24, 2021 - Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the Biologics...
Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder
on September 20, 2021 at 2:09 am
RADNOR, Pa.--(BUSINESS WIRE) September 20, 2021 -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the U.S. Food and Drug...
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
on September 20, 2021 at 1:09 am
PRINCETON, N.J.--(BUSINESS WIRE) September 22, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking...
Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
on September 20, 2021 at 1:09 am
WEST CHESTER, PA – September 20, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical...
ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids
on September 15, 2021 at 2:09 am
GENEVA, Switzerland– September 15, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced that it has...
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine
on September 14, 2021 at 2:09 am
NEW YORK, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that...
FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease
on September 2, 2021 at 8:09 pm
NDA supported by positive data from Phase 3 CHELATE clinical trial TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease Paris, France – 02 September 2021 – Orphalan SA, a...
Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
on September 1, 2021 at 9:09 pm
SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS)...
Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
on August 25, 2021 at 4:08 am
Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 25, 2021-- Moderna, Inc. (Nasdaq:...
Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
on August 25, 2021 at 1:08 am
New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing titers against the wild-type strain one month...
Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
on August 24, 2021 at 12:08 am
BOSTON, Aug. 24, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving...
Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
on August 23, 2021 at 9:08 pm
NEW YORK, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that...
Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
on August 17, 2021 at 2:08 am
CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today...
Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
on August 13, 2021 at 3:08 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a...
Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
on August 13, 2021 at 12:08 am
Paris (France), Friday 13 August, 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene....
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
on August 11, 2021 at 12:08 am
SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application...