资讯

Gene Therapy Stocks Fall as FDA Pushes Out Another Top Regulator
The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...
FDA cell and gene therapy director exit increases ‘volatility’ for sector
Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...
Fierce Biotech13 小时
Industry deeply disappointed as FDA reportedly puts cell and gene therapy chief on leave
The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its ...
STAT23 小时
FDA’s gene therapy turmoil, and an alternative model for funding research
We look at the continued turmoil within the FDA, including the forced dismissal of top gene therapy regulator Nicole Verdun, ...
BioPharma Dive4 小时
Gene therapy faces fresh uncertainty as two more top FDA officials depart
The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about ...
Analyst Downgrades Sarepta As Elevidys Safety Clouds Future Demand
Sarepta shares face pressure after a second Elevidys-linked death and analyst downgrade over safety concerns and lowered ...
Fintel on MSN6 小时
William Blair Downgrades Sarepta Therapeutics (SRPT)
Fintel reports that on June 20, 2025, William Blair downgraded their outlook for Sarepta Therapeutics (NasdaqGS:SRPT) from ...
STAT1 小时
Disagreements over Duchenne therapy, management style may have led to ouster of key FDA ...
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
Medical Marketing & Media6 小时
Rx Rundown: Sanofi, Processa Pharmaceuticals, Eli Lilly and more
AstraZeneca signed a potential $5 billion research deal with Chinese drugmaker CSPC. Eli Lilly is buying Verve Therapeutics for $1 billion upfront plus a CVR potentially worth another $300 million.
FDA，“余震”不断
而继续沿着事实逻辑看，就会发现，在FDA资深人士大批离开后，新药评审所需的专业能力是减弱而非得到加强。因此，行业的观察是，FDA对新的IND、BLA以及NDA的审批速度将大大减慢，许多产品和公司可能要“面临漫长而昂贵的停滞期，迟迟得不到任何进展”。