Approvals

FDA approves Gilead’s HIV PrEP drug Descovy

Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for HIV pre-exposure prophylaxis (PrEP) indication of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).

Merck’s KEYTRUDA approved as monotherapy in China for first-line treatment of certain patients with advanced NSCLC

Merck announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by a NMPA-approved test, with no EGFR or ALK genomic tumor aberrations.

Roche gets FDA nod for Rituxan to treat children with two blood vessel disorders

Roche has secured approval from the US Food and Drug Administration (FDA) for its Rituxan (rituximab), in combination with glucocorticoids, to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients two years of age and older.

FDA approves Ipsen’s Dysport to treat upper limb spasticity in children

Ipsen Biopharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Dysport (abobotulinumtoxinA) to treat upper limb spasticity in children.

Aldeyra Therapeutics receives fast track designation for ADX-2191 for prevention of proliferative vitreoretinopathy

Aldeyra Therapeutics announced that the US Food and Drug Administration (FDA) has granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is a serious, sight-threatening condition with no approved treatment.

FDA grants fast track status to Annexon’s ANX005 to treat Guillain-Barré Syndrome

Annexon Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its novel C1q inhibitor, ANX005, to treat Guillain-Barré Syndrome (GBS).

FDA grants orphan drug designation to Reneo Pharmaceuticals for REN001 to treat fatty acid oxidation disorders

Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).

FDA approves Merck’s Pifeltro and Delstrigo for virologically suppressed HIV-1 patients

Merck has secured approval from the US Food and Drug Administration (FDA) for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) to treat appropriate adults living with HIV-1 who are virologically suppressed.

SanBio gets FDA RMAT designation for SB623 cell therapy

SanBio has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its SB623 cell therapy to treat chronic neurological motor deficits secondary to traumatic brain injury (TBI).