Drug Filing

Bristol-Myers Squibb, Acceleron announce FDA advisory committee will review Reblozyl for use in patients with MDS

Bristol-Myers Squibb and Acceleron Pharma said that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on December 18, 2019.

Merck’s Keytruda gets FDA priority review for high-risk NMIBC

Merck said that its anti-PD-1 therapy Keytruda has been granted priority review by the US Food and Drug Administration (FDA) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).

AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC

AstraZeneca has secured priority review from the US Food and Drug Administration (FDA) for its cancer drug Imfinzi (durvalumab) for the treatment of extensive-stage small cell lung cancer (SCLC) in previously untreated patients.

Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a medical dermatology company, announced that its New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is July 13, 2020.

Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention of pregnancy

Evofem Biosciences, Inc., a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Amphora, a Multipurpose Vaginal pH Regulator (MVP-R), for the prevention of pregnancy.

FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma

The US Food and Drug Administration (FDA) has accepted Incyte’s new drug application (NDA) for the priority review of its pemigatinib to treat patients with cholangiocarcinoma.

FDA grants breakthrough therapy designation to Usona Institute’s psilocybin for major depressive disorder

Usona Institute has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for psilocybin in the treatment of major depressive disorder (MDD).

Newron’s sarizotan secures FDA rare paediatric status in Rett syndrome

Newron Pharmaceuticals has secured rare paediatric disease designation for sarizotan from the US Food and Drug Administration (FDA) for the treatment of Rett syndrome.

US FDA accepts regulatory submission for Selumetinib

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs)