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 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 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.
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 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.
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).
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).
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 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).
Roche has secured a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its Gazyva (obinutuzumab) to treat adults with lupus nephritis.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.