Regeneron Provides Update on Biologics License Application for Odronextamab
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2024 Category: Drugs & Pharmacology Source Type: news

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or“the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 18, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib
MIAMI--(BUSINESS WIRE) March 13, 2024 --Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 13, 2024 Category: Drugs & Pharmacology Source Type: news

Lumicell Announces FDA Advisory Committee ’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving Surgery
NEWTON, Massachusetts March 6, 2024– Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 6, 2024 Category: Drugs & Pharmacology Source Type: news

SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN
STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 4, 2024 Category: Drugs & Pharmacology Source Type: news

Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type C
CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced 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 - March 4, 2024 Category: Drugs & Pharmacology Source Type: news

Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2024 Category: Drugs & Pharmacology Source Type: news

Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2024 Category: Drugs & Pharmacology Source Type: news

BeiGene ’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.--(BUSINESS WIRE) February 27, 2024 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2024 Category: Drugs & Pharmacology Source Type: news

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
Malvern, PA, and Parsippany, NJ– February 23, 2024– Venatorx Pharmaceuticals (Venatorx) and Melinta Therapeutics (Melinta) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 23, 2024 Category: Drugs & Pharmacology Source Type: news

Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review
TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 21, 2024 Category: Drugs & Pharmacology Source Type: news

FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse glioma
Boston, MA, Suresnes, France, February 20 2024– Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 20, 2024 Category: Drugs & Pharmacology Source Type: news

Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer
Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer 19 February... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2024 Category: Drugs & Pharmacology Source Type: news

Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU
Zug, Switzerland– February 14, 2024– Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 14, 2024 Category: Drugs & Pharmacology Source Type: news

Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma
CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ( " Citius " or the " Company " ) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2024 Category: Drugs & Pharmacology Source Type: news