In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development…

Aprea Therapeutics has received FDA clearance to continue its eprenetapopt development, with the lifting of a full clinical hold placed last summer on the drug’s nonHodgkin’s lymphoma clinical trial program.…

The FDA has revised Pfizer/BioNTech’s Emergency Use Authorization (EUA), allowing a booster of the companies’ COVID-19 vaccine in teenagers aged 16 and 17 six months following completion of a primary…

The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune…

Roche has partnered with Recursion to generate up to 40 new neuroscience and cancer therapies using the Utah-based biotech firm’s machine-learning drug discovery platform. Source: Drug Industry Daily

The Pfizer/BioNTech and Moderna COVID-19 vaccines are 25-40 times less effective against the new Omicron variant than the original strain and Delta variants, two new laboratory studies have found. Source:…

Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Source: Drug Industry Daily

An FDA advisory committee unanimously rejected recommending approval of Reata Pharmaceuticals’ bardoxolone methyl as a treatment for patients 12 years and up with chronic kidney disease caused by Alport syndrome…

Cutting prices for costly therapies approved under an accelerated pathway may not significantly reduce total prescription drug spending by Medicare, says a new study by researchers at Brigham and Women’s…

The FDA offered guidance for sponsors of individualized drugs developed for use against life-threatening genetic diseases in two draft guidances released yesterday. Source: Drug Industry Daily