FDA Issues Complete Response Letter for Satsuma ’s STS101
TOKYO and KAGOSHIMA, Japan, January 18, 2024– Shin Nippon Biomedical Laboratories, Ltd. (TSE Prime: 2395, Chairman and President: Ryoichi Nagata, M.D., Ph.D.,“SNBL”) announced today that its wholly-owned US subsidiary, Satsuma... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 18, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Acceptance of Zevra's Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to LadRx
EMERYVILLE, Calif., Jan. 11, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation XOMA, the biotech royalty aggregator, announced today that based upon the U.S. Food and Drug Administration's (FDA) acceptance of Zevra Therapeutics' New Drug Application (NDA) for arimoclomol, an orally-delivered,…#emeryville #xomacorporationxoma #fda #nda #npc #xoma #ladrx #arimoclomol #bradsitko #zevra (Source: Reuters: Health)
Source: Reuters: Health - January 11, 2024 Category: Consumer Health News Source Type: news
Requests for Reconsideration at the Division Level Under GDUFA
This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 10, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Grants Soligenix Fast Track Designation for Dusquetide in the Treatment of Oral Lesions of Beh çet's Disease
PRINCETON, N.J., Jan. 8, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2024 Category: Drugs & Pharmacology Source Type: news
Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
TOKYO, Jan. 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2024 Category: Drugs & Pharmacology Source Type: news
Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
SCOTTSDALE, Ariz., Jan. 05, 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 - January 5, 2024 Category: Drugs & Pharmacology Source Type: news
Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration
CELEBRATION, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. ZVRA a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC) to…#celebration #fla #zevratherapeuticsinc #newdrugapplication #nda #npc #fda #pdufa #zevra #neilmcfarlane (Source: Reuters: Health)
Source: Reuters: Health - December 27, 2023 Category: Consumer Health News Source Type: news
Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration
CELEBRATION, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA) for arimoclomol, an investigational therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 27, 2023 Category: Drugs & Pharmacology Source Type: news
Amgen Provides Regulatory Update on Status of Lumakras (sotorasib)
THOUSAND OAKS, Calif., Dec. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company ' s supplemental New Drug Application seeking full approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 26, 2023 Category: Drugs & Pharmacology Source Type: news
Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT
MONTREAL and CHARLOTTE, N.C., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. MIST announced today that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for self-administered etripamil nasal…#montreal #charlotte #mist #rtf #fda #newdrugapplication #nda #josepholiveto #lancet #rapid (Source: Reuters: Health)
Source: Reuters: Health - December 26, 2023 Category: Consumer Health News Source Type: news
Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT
MONTREAL and CHARLOTTE, N.C., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced today that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 26, 2023 Category: Drugs & Pharmacology Source Type: news
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 22, 2023 Category: Drugs & Pharmacology Source Type: news
Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome
Copenhagen, Denmark, December 22, 2023– Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 22, 2023 Category: Drugs & Pharmacology Source Type: news
Camurus Submits New Drug Application to the US FDA for Oclaiz ™ for Treatment of Acromegaly
Lund, Sweden— 21 December 2023— Camurus (NASDAQ STO: CAMX) today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OclaizTM (CAM2029), the company’s investigational,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2023 Category: Drugs & Pharmacology Source Type: news
Camurus Submits New Drug Application to the US FDA for Oclaiz for Treatment of Acromegaly
Lund, Sweden— 21 December 2023— Camurus (NASDAQ STO: CAMX) today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OclaizTM (CAM2029), the company’s investigational,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2023 Category: Drugs & Pharmacology Source Type: news
