Tag Archives: regulator

TO APPRECIATE the dilemmas the Food and Drug Administration (FDA) faces when it reviews new drugs targeting rare diseases, consider the recent rollercoaster ride of Sarepta Therapeutics, a biotech firm. In 2023 the FDA granted accelerated approval for its gene therapy for Duchenne muscular dystrophy, a rare genetic disorder that typically causes death in early adulthood. Peter Marks, director of …

Vinay Prasad returns to role as top vaccine regulator at FDA days after leaving US agency  Reuters Top vaccine regulator returns to FDA after recent firing  Politico Loomer Rages at Return of FDA Chief She Pushed to Oust Over ‘Voodoo’ Claims  The Daily Beast UCSF doctor reinstated at FDA less than 2 weeks after resigning amid MAGA backlash  San Francisco Chronicle Vinay Prasad returns …

FDA regulator reinstalled less than two weeks after White House ouster  The Washington Post Top vaccine regulator returns to FDA after recent firing  Politico FDA official returns to agency after Loomer-led ouster  CNN Ousted F.D.A. Vaccine Chief Returns to Agency  The New York Times Vinay Prasad returns to role as top vaccine regulator at FDA days after leaving US agency  Reuters Source link

Top vaccine regulator returns to FDA after recent firing  Politico Vinay Prasad returns to the FDA, weeks after his ouster  statnews.com Ousted Vaccine Regulator Vinay Prasad To Return to FDA  Bloomberg.com UCSF professor resigns from Trump’s FDA after right-wing conspiracy theorist calls him ‘leftist saboteur’  The Mercury News Navigating the Precipice: Sarepta’s Turbulent Journey and the Biotech Innovation Paradox  AInvest Source link

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. The top regulator of cancer drugs at the Food and …

What the ouster of a top FDA regulator shows about Trump world divisions  The Washington Post FDA vaccine chief leaving agency after less than 3 months  AP News Are we sure Vinay Prasad’s ouster is positive for biotech?  statnews.com Trump drove firing of FDA official  Politico US FDA’s top vaccine official Vinay Prasad leaves agency after 3 months  Reuters Source link

China’s cyberspace regulator has summoned Nvidia to explain whether its H20 chips have any “back-door safety” risks, casting a shadow over the US chip giant’s local operations. The Cyberspace Administration of China (CAC), the agency responsible for cybersecurity, said in a statement on Thursday that it had summoned and interviewed Nvidia regarding the risks associated with the potential tracking and …

Top FDA vaccine regulator under Trump ousted amid conservative criticism  The Washington Post U.S. FDA’s chief medical and science officer Prasad departs agency  CNBC US FDA’s Vinay Prasad leaves health regulator, STAT News reports  Reuters Opinion | Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag  The Wall Street Journal Controversial FDA official Dr. Vinay Prasad departs agency  CNN Source link

LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus’ transmission. In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is “highly effective” and “considered to be of …

EU regulator backs Gilead’s twice-yearly injection for HIV prevention  Reuters E.U. regulator approves injectable HIV drug that experts say could help stop transmission  NBC News EU regulators back twice-yearly HIV injection  Euronews.com Yeztugo approval: A new era in HIV prevention  Newsday Expert: Lenacapavir Shows 100% Efficacy in Key Trial, Offering Transformative Twice-Yearly HIV Prevention  Pharmacy Times Source link