Regulation

Santhera seeks EMA approval for idebenone in Duchenne muscular dystrophy

Santhera Pharmaceuticals has filed a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).

Celgene gets FDA nod for blood cancer drug combo Revlimid plus rituximab

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Revlimid (lenalidomide) in combination with a rituximab product (R²) to treat adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).

Teva reaches agreement with Oklahoma to resolve state’s claims

Teva Pharmaceuticals USA and related affiliates of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and the state of Oklahoma, have entered into an agreement for a one-time payment of $85 million to the state.

Novartis gets FDA nod for breast cancer drug combo Piqray plus fulvestrant

Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.

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.