Approvals

FDA approves gene therapy to treat pediatric patients with spinal muscular atrophy

The US Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.

GSK gets Chinese approval for shingles vaccine Shingrix

GlaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster) in adults aged 50 years or older.

FDA approves SORILUX for adolescent plaque psoriasis

Mayne Pharma Group has announced that the US Food and Drug Administration (FDA) has approved SORILUX (calcipotriene) Foam, 0.005% in adolescents.

US FDA approves GATTEX for children with short bowel syndrome

Takeda Pharmaceuticals, announced today that the US Food and Drug Administration (FDA) approved extending the indication of GATTEX (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding.

Pfizer’s blood clot drug Fragmin gets FDA approval for pediatric patients

Pfizer has secured approval from the US Food and Drug Administration (FDA) for the subcutaneous use of Fragmin (dalteparin sodium) injection for the treatment of potentially life-threatening blood clots in pediatric patients.

FDA approves Roche’s leukemia drug combo Venclexta plus Gazyva

Roche has secured approval from the US Food and Drug Administration (FDA) for its Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) to treat people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Pfizer, Merck get FDA nod for Bavencio plus Inlyta to treat advanced RCC

Pfizer and Merck have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) in combination with Inlyta (axitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC).

Lilly’s Cyramza becomes first FDA-approved biomarker-driven therapy in patients with hepatocellular carcinoma

Eli Lilly announced that the US Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

Celgene gets FDA breakthrough therapy designation for Pomalyst to treat Kaposi sarcoma

Celgene has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Pomalyst (pomalidomide) to treat patients with human immunodeficiency virus (HIV)-positive and negative Kaposi sarcoma.