Approvals

Pfizer, Astellas secure expanded FDA approval for XTANDI

Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in metastatic castration-sensitive prostate cancer (mCSPC).

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.

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.

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).

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).

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).

Alnylam announces approval of GIVLAARI by US FDA

Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced today that the US Food and Drug Administration (FDA) approved GIVLAARI (givosiran) injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP).