June 23, 2023
For the first time, the US Food and Drug Administration (FDA) has released draft guidance highlighting “fundamental considerations” for researchers designing clinical trials testing psychedelic drugs […]
June 23, 2023
(Reuters) – The U.S. health regulator has granted accelerated approval to Sarepta Therapeutics’ first-of-its-kind gene therapy for Duchenne muscular dystrophy (DMD), an inherited progressive muscle-wasting disorder […]
June 22, 2023
The US Food and Drug Administration (FDA) has rejected Intercept Pharmaceutical’s second bid for approval of obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with […]
June 21, 2023
The US Food and Drug Administration (FDA) has approved the oral PARP inhibitor talazoparib (Talzenna, Pfizer) plus enzalutamide (Xtandi) to treat homologous recombination repair (HRR) gene–mutated […]
June 20, 2023
The US Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the […]
June 16, 2023
The US Food and Drug Administration (FDA) has granted accelerated approval for glofitamab (Columvi) for use in certain types of lymphoma. The indication is for use […]
June 13, 2023
The US Food and Drug Administration (FDA) has expanded the indication for odevixibat (Bylvay) to include treatment of cholestatic pruritus associated with Alagille syndrome (ALGS) in […]
June 12, 2023
The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age 6 years with functional constipation, making […]
June 9, 2023
The US Food and Drug Administration (FDA) is reminding healthcare providers and facilities about the recent recall of certain oxygenators used for extracorporeal circulation. On May […]