All articles tagged with #vinay prasad
Under acting director Karim Mikhail, the FDA’s Center for Biologics Evaluation and Research is trying to move past a turbulent period by holding adviser meetings and showing flexibility in accepting drug submissions, signaling a return to a more normal operating stance after Vinay Prasad's controversial tenure.
Vijay Kumar, acting director of FDA’s Office of Therapeutic Products that reviews cell and gene therapies, is stepping down and not renewing his detail. His departure comes amid broader leadership turnover at the agency’s Center for Biologics Evaluation and Research, where the cell-and-gene-therapy office is housed. Kumar had been promoted to lead the office by Vinay Prasad after Verdun’s ouster a little over a year ago, highlighting continuing leadership shake-ups within the FDA.
UniQure’s Huntington’s disease gene therapy AMT-130 is back on track for FDA accelerated approval after the ouster of Vinay Prasad and other Trump-era regulators; the agency now accepts a standard-care control arm instead of sham surgeries, with a filing anticipated in Q3.
Vinay Prasad is set to leave the FDA for the second time, with his tenure marked by controversy, including a rejected mRNA vaccine, a controversial demand for an extra trial on a Huntington’s gene therapy from UniQure, public clashes with the company and alleged staff abuse, drawing mixed reactions from biotech investors and patient advocates as a replacement is named.
A STAT opinion piece assesses Vinay Prasad's tumultuous FDA tenure, noting his push for clearer, stronger data in rare-disease approvals but arguing his impulsive, confrontational approach caused chaos and eroded the agency's credibility; his upcoming departure leaves a controversial legacy about balancing rigorous evidence with regulatory pragmatism.
FDA vaccine chief Dr. Vinay Prasad is leaving the agency at the end of April to return to UCSF, marking a second departure in under a year amid ongoing controversies over vaccine and rare-disease drug reviews, including disputes with Moderna over an mRNA flu vaccine and with UniQure on a Huntington's disease gene therapy.
Vinay Prasad, the FDA’s top vaccine official, is departing at the end of April to return to UCSF, marking a second exit in under a year amid ongoing tensions over vaccine and biotech drug reviews, including a controversial rejection of Moderna’s mRNA flu vaccine that was later reversed under White House pressure.
Dr. Vinay Prasad, a divisive FDA vaccine regulator who overruled career scientists and pressed a crackdown on a biotech firm, is resigning at the end of April after a turbulent tenure that included a brief dismissal sparked by Laura Loomer’s attack and a later reinstatement urged by FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr.
Vinay Prasad, a high-profile FDA official who oversaw vaccines, gene therapies, and rare-disease drug decisions, will leave the agency at the end of April amid ongoing leadership turnover and criticism over regulatory decisions and management style.
Vinay Prasad, the FDA’s controversial head of vaccines and complex therapies, will step down at the end of April after a tenure marked by divisive drug and vaccine decisions and a push to tighten vaccine approvals; his tenure included a prior brief removal and quick reinstatement in 2025.
An opinion piece argues that FDA leaders Peter Marks and Vinay Prasad have pursued a rigorous, aggressive regulatory approach that comes with costs for biotech firms and patients, fueling debate over approving drugs with uncertain benefits.
AP reports that FDA Commissioner Marty Makary’s voucher-based effort to accelerate drug approvals into a one-month window has stirred alarm inside the agency. Questions swirl over who has legal authority to sign off on these expedited approvals, with senior officials and political appointees increasingly involved in the process, diverging from the traditional scientist-led review. The program, not codified in federal rules and now expanded to 18 vouchers, has coincided with staff layoffs and leadership turnover, fueling concerns about politicization, safety standards, and potential legal risk for the agency as critics warn that such rapid reviews lack scientific precedent.
Biotech shares experienced volatility following the surprise reinstatement of FDA official Vinay Prasad, whose return raises concerns about political influence affecting drug approval processes amid leadership turmoil within the FDA, impacting companies like Sarepta and Replimune.
The FDA has rehired Dr. Vinay Prasad as the head of its vaccines and gene therapy division after he resigned due to pressure from Laura Loomer, a far-right activist, despite opposition from key officials. Prasad, known for his vaccine skepticism, was previously appointed by Health Secretary RFK Jr. and had limited COVID-19 vaccine use. His reappointment has sparked controversy, especially among Trump supporters.
Vinay Prasad, who briefly left the FDA amid controversy, has returned to oversee vaccine, gene therapy, and blood products, following pressure and criticism related to his handling of gene therapy safety issues and political attacks from Laura Loomer.