Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
Foster City, Calif., October 27, 2022 – The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for bulevirtide, an investigational entry-inhibitor for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2022 Category: Drugs & Pharmacology Source Type: news
Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review
If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic
PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter
FDA advised that they are not currently planning to hold an Advisory... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 26, 2022 Category: Drugs & Pharmacology Source Type: news
Novaliq Announces FDA Acceptance of the New Drug Application for CyclaSol for the Treatment of Dry Eye Disease
PDUFA target action date is June 8, 2023
HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022– Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 24, 2022 Category: Drugs & Pharmacology Source Type: news
Biogen Announces FDA ’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023
CAMBRIDGE, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2022 Category: Drugs & Pharmacology Source Type: news
Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2022 Category: Drugs & Pharmacology Source Type: news
Travere Therapeutics Provides Regulatory Update on its Sparsentan Program for IgA Nephropathy
SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that following late-cycle review interactions with the U.S. Food and Drug Administration (FDA), the Company expects the previously assigned... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 13, 2022 Category: Drugs & Pharmacology Source Type: news
BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA
BLA Includes Substantial Body of Data from Pivotal Phase 3 and Ongoing Phase 1/2 Studies
If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A
SAN RAFAEL, Calif., Sept. 29, 2022 /PRNewswire/ -- BioMarin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2022 Category: Drugs & Pharmacology Source Type: news
Spectrum Pharmaceuticals Provides Update on Poziotinib Following FDA Oncologic Drugs Advisory Committee Meeting
BOSTON--(BUSINESS WIRE)--Sep. 22, 2022-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) (“Spectrum” or the“Company”), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2022 Category: Drugs & Pharmacology Source Type: news
Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis
Assigned PDUFA target action date of March 22, 2023
SAN DIEGO, Sept. 20, 2022— Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 20, 2022 Category: Drugs & Pharmacology Source Type: news
Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA
NDA granted priority review
Prescription Drug User Fee Act action date set for March 12, 2023
SAN DIEGO–(BUSINESS WIRE)–Sep. 12, 2022– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2022 Category: Drugs & Pharmacology Source Type: news
BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization
Submission based on overwhelmingly positive top-line results from GENESIS Phase 3 study
Stem cell mobilization for bone marrow transplantation estimated to be> $360 million market in the U.S. (> $500 million globally), with consistent... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2022 Category: Drugs & Pharmacology Source Type: news
FDA and EMA Accept Regulatory Submission for Pfizer ’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata
Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo
NEW YORK--(BUSINESS WIRE) September 09, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 9, 2022 Category: Drugs & Pharmacology Source Type: news
Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
FDA Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS
If approved, AMX0035 will be the first treatment in ALS that has demonstrated a significant... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 7, 2022 Category: Drugs & Pharmacology Source Type: news
Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
IRVINE, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 7, 2022 Category: Drugs & Pharmacology Source Type: news
Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane)
PDUFA Action Date is June 28, 2023
VAUGHAN, Ontario and HEIDELBERG, Germany, Sept. 6, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ( " Bausch + Lomb " ), a leading global eye health company dedicated to helping people see... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 6, 2022 Category: Drugs & Pharmacology Source Type: news
