Regulation

Meitheal Pharmaceuticals announces FDA approval of Enoxaparin Sodium Injection, USP

Meitheal Pharmaceuticals, a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox.

ViiV Healthcare seeks FDA approval for fostemsavir to treat HIV-1 infection

ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.

Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

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.

Roche gets FDA nod for Tecentriq plus chemotherapy to treat metastatic NSCLC

Roche has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) plus chemotherapy for the initial treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

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.