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
Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administration
Submission seeks approval of momelotinib for the treatment of myelofibrosis
SAN MATEO, Calif.--(BUSINESS WIRE) June 17, 2022 -- Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 17, 2022 Category: Drugs & Pharmacology Source Type: news
Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome
DUBLIN, June 13, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced the resubmission of the Company ' s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 13, 2022 Category: Drugs & Pharmacology Source Type: news
Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data
CAMBRIDGE, Mass.--(BUSINESS WIRE) June 3, 2022 -- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the“Company”)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 8, 2022 Category: Drugs & Pharmacology Source Type: news
Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel
Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant
Omidubicel has Orphan... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 2, 2022 Category: Drugs & Pharmacology Source Type: news
Eagle Pharmaceuticals Announces Submission of New Drug Application to U.S. Food and Drug Administration for Landiolol, a Beta-1 Adrenergic Blocker
Submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter
Expected approval mid-year 2023, if accepted by FDA for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2022 Category: Drugs & Pharmacology Source Type: news
TG Therapeutics Announces FDA Extension of BLA PDUFA Date for Ublituximab to Treat Patients with RMS
New PDUFA goal date of December 28, 2022
NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has extended... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 31, 2022 Category: Drugs & Pharmacology Source Type: news
