The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its ...

The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...

Shares of gene editing companies were largely steady in the premarket on Friday after the FDA’s Center for Biologics Research ...

Sarepta shares face pressure after a second Elevidys-linked death and analyst downgrade over safety concerns and lowered ...

The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

An off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results, according to a new study.

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.

Capricor shares four-year data showing Deramiocel slowed DMD progression and preserved function, with maintained safety in long-term use.

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”。