Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review
If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant
PDUFA target action date is January 30, 2023
BOSTON--(BUSINESS WIRE)--Aug. 1, 2022--... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 1, 2022 Category: Drugs & Pharmacology Source Type: news
Cidara Therapeutics Submits NDA for Rezafungin
Submitted NDA for rezafungin for candidemia and invasive candidiasis to the U.S. FDA on July 22, 2022, with an anticipated PDUFA target action date in the first quarter of 2023, if accepted for review following application validation
Melinta... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2022 Category: Drugs & Pharmacology Source Type: news
Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
The Woodlands, Texas, July 27, 2022– Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and filed its New Drug Application (NDA) for sotagliflozin, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2022 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Biogen ’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS
SOD1-ALS is a rare genetic form of ALS that affects approximately 330 people in the U.S.,1 it is progressive, leads to the loss of everyday functions and is uniformly fatal
If approved, tofersen would be the first treatment to target a genetic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 26, 2022 Category: Drugs & Pharmacology Source Type: news
Treosulfan NDA Resubmitted to FDA
TORONTO and CHICAGO, July 25, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for treosulfan... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 25, 2022 Category: Drugs & Pharmacology Source Type: news
Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs
Acer has notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection
NEWTON, MA– July 18, 2022– Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 18, 2022 Category: Drugs & Pharmacology Source Type: news
Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome
SAN DIEGO–(BUSINESS WIRE)–Jul. 18, 2022– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 18, 2022 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Byondis ’ Biologics License Application for [Vic-]Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer
12 July 2022 -- Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, announced today that the U.S. Food& Drug Administration (FDA) accepted the company’s submission of a Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 12, 2022 Category: Drugs & Pharmacology Source Type: news
Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)
VAUGHAN, ON and HEIDELBERG, Germany, July 7, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ( " Bausch + Lomb " ), a leading global eye health company dedicated to helping people see better to live... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 7, 2022 Category: Drugs & Pharmacology Source Type: news
Pfizer Announces Submission of New Drug Application to the U.S. FDA for Paxlovid
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk for progression to severe illness from COVID-19; consistent with current emergency use authorization
Final results from EPIC-HR... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 30, 2022 Category: Drugs & Pharmacology Source Type: news
Ipsen Announces U.S. FDA Priority Review for Palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission
PARIS--(BUSINESS WIRE)--Regulatory News: June 29, 2022 -- Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its resubmitted New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2022 Category: Drugs & Pharmacology Source Type: news
Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application
CAMBRIDGE, Mass., June 27, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2022 Category: Drugs & Pharmacology Source Type: news
Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 27, 2022-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2022 Category: Drugs & Pharmacology Source Type: news
Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause
TOKYO, June 23, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 23, 2022 Category: Drugs & Pharmacology Source Type: news
Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Priority Review requested; if accepted, anticipate an 8-month FDA review
Positive EMERALD study data previously announced on October 20, 2021
First, and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 22, 2022 Category: Drugs & Pharmacology Source Type: news
