Regulation

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 approves Oxbryta (Voxelotor), the first medicine specifically targeting the root cause of sickle cell disease

Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older.

Celltrion Healthcare gets EC approval for its subcutaneous formulation of biosimilar infliximab, Remsima

Celltrion Healthcare has secured approval from the European Commission (EC) for its Remsima SC (CT-P13 SC), a subcutaneous formulation of biosimilar infliximab, Remsima, to treat patients with rheumatoid arthritis (RA).

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).

SOLIRIS receives approval in Japan for the prevention of relapse in patients with neuromyelitis optica spectrum disorder

Alexion Pharmaceuticals announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the extension of the current marketing authorization of SOLIRIS (eculizumab) to include the prevention of relapse in patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.

FDA approves AstraZeneca’s Calquence to treat lymphocytic cancers

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Calquence (acalabrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).