TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ ® (U2) to Treat Patients with CLL and SLL
NEW YORK, March 03, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to June 25, 2022 for the Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 3, 2022 Category: Drugs & Pharmacology Source Type: news
Nymox Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate
IRVINE, Calif., March 03, 2022 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the“Company”) is pleased to announce today that it has submitted the Company’s New Drug Application (NDA) to the FDA for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 3, 2022 Category: Drugs & Pharmacology Source Type: news
Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues
CRL Cites Issues Related to Compatibility of Vials and Lenacapavir Solution
No New Clinical Studies Requested in the CRL
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 1, 2022-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2022 Category: Drugs & Pharmacology Source Type: news
Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022
The Woodlands, Texas, February 28, 2022 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the voluntary withdrawal and planned near-term resubmission of the company’s New Drug Application (NDA) for sotagliflozin to correct a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2022 Category: Drugs & Pharmacology Source Type: news
Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA
DUBLIN, Ireland, and Boston, MA, February 28, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announced it has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2022 Category: Drugs & Pharmacology Source Type: news
Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome
PLANO, Texas--(BUSINESS WIRE) February 25, 2022 -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the“Company,” or“we”), 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 25, 2022 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration (FDA) Accepts Mirati Therapeutics' New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer
SAN DIEGO, Feb. 15, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 15, 2022 Category: Drugs & Pharmacology Source Type: news
Orphazyme Provides Update for Planned NDA Resubmission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C in the United States
Copenhagen, Denmark, February 11, 2022 – Orphazyme A/S (ORPHA.CO; ORPH) (“Orphazyme” or the“Company”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 11, 2022 Category: Drugs & Pharmacology Source Type: news
Spectrum Pharmaceuticals Announces Acceptance of New Drug Application Filing for Poziotinib
HENDERSON, Nev.--(BUSINESS WIRE)--Feb. 11, 2022-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that its New Drug Application (NDA) for poziotinib has been... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 11, 2022 Category: Drugs & Pharmacology Source Type: news
Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction
SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food& Drug Administration (FDA) has accepted and filed the company’s New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 4, 2022 Category: Drugs & Pharmacology Source Type: news
Reata Pharmaceuticals Initiates Rolling Submission of New Drug Application with U.S. FDA for Omaveloxolone for the Treatment of Patients with Friedreich ’s Ataxia
If Approved, Omaveloxolone Would Become the First Therapy Indicated for the Treatment of Patients with Friedreich’s Ataxia
PLANO, Texas--(BUSINESS WIRE) January 31, 2022 -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA),... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 31, 2022 Category: Drugs & Pharmacology Source Type: news
Incyte Provides Update on Parsaclisib and MCLA-145
WILMINGTON, Del.--(BUSINESS WIRE) January 25, 2022 -- Incyte (Nasdaq:INCY) today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2022 Category: Drugs & Pharmacology Source Type: news
Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency
NEW YORK& MIAMI--(BUSINESS WIRE) January 21, 2022 -- Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 21, 2022 Category: Drugs & Pharmacology Source Type: news
Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults with Type 2 Diabetes
The Woodlands, Texas, December 30, 2021– Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 30, 2021 Category: Drugs & Pharmacology Source Type: news
Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the Treatment of ALS
CAMBRIDGE, Mass.--(BUSINESS WIRE) December 29, 2021 -- Amylyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 29, 2021 Category: Drugs & Pharmacology Source Type: news
