FDA
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
The appointment of Richard Pazdur, currently director of the FDA’s Oncology Center of Excellence, comes less than a week after he reportedly declined the post, and just nine days after his predecessor’s controversial exit.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease.
The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. This webinar explores the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.