The FDA’s Center for Biologics and Evaluation Research (CBER) put out its planned list of guidance documents it expects to release in 2022, including several that focus on gene therapies…

A new draft guidance from the FDA describes the benefit-risk principles the agency would apply when evaluating product quality for New Drug Applications (NDAs), Biologics License Applications (BLAs) or supplements…

In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a…

The industry is speaking out about worries that must-pass legislation that reauthorizes FDA’s user fee programs might get bogged down with lawmakers’ projects and other effluvium that could alter the…

Novartis has paused production of two radioligand cancer therapies manufactured at its Ivrea, Italy, and Millburn, N.J., plants after potential quality issues surfaced. Source: Drug Industry Daily

Almost 11 years after it granted Accelerated Approval, the FDA is withdrawing approval for Celgene’s (now Bristol Myers Squibb’s) peripheral T-cell lymphoma (PTCL) indication for Istodax (romidepsin) after the cancer…

After resolving drug quality issues, Marinus Pharmaceuticals has resumed screening and recruitment for a phase 3 trial of its investigational drug ganaxolone in refractory status epilepticus (RSE). Source: Drug Industry…

AstraZeneca’s complement-5 inhibitor Ultomiris (ravulizumab-cwvz) has shown benefit in people living with a rare degenerative neuromuscular disorder called anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Source: Drug Industry…

The FDA granted AstraZeneca a Priority Review for its blockbuster oncology drug, Imfinzi (durvalumab), combined with chemotherapy, for treatment of patients with locally advanced or metastatic biliary tract cancer (BTC),…

FDA Commissioner Robert Califf has said the FDA still has a lot of work to do with regard to the pandemic, and in particular, he doesn’t think the agency is…