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At ASCO, BioNTech and Pfizer promoted new bispecific cancer data while senior FDA oncology official Rick Pazdur argued agency disruption could become a chance to rebuild.

Revolution Medicines has started shipping an experimental pancreatic cancer drug, and its CEO says an FDA submission is coming soon.

The FDA has approved Gilead’s hepatitis D drug Hepcludex, ending a four-year wait after the therapy was previously rejected over manufacturing and distribution problems.

STAT reports that acting FDA drug center head Tracy Beth Høeg is leaving the agency, widening a leadership vacuum that followed Commissioner Marty Makary’s resignation.

Endpoints News identified Marty Makary’s resignation as the week’s biggest health story, underscoring how quickly leadership changes at the FDA can dominate the sector’s outlook.

The Supreme Court preserved current mail access to mifepristone for now, leaving existing distribution protocols in place while litigation continues.

The head of the FDA’s drug division, Tracy Beth Høeg, is expected to leave the agency following the recent exit of Commissioner Marty Makary, according to a source familiar with the matter.

Multiple reports say FDA Commissioner Marty Makary is expected to be fired, though the plans were described as not yet final. The prospect of a sudden leadership change is drawing attention to how quickly political moves

The FDA is rolling out a framework that could allow certain individualized gene therapies to reach patients with rare genetic disorders without human clinical trials, accelerating access while raising serious safety and信

A new episode of STAT News’ Readout LOUD podcast centers on Seaport Therapeutics’ IPO, battles over obesity pills, and the political troubles surrounding FDA Commissioner Marty Makary.

The FDA is reconsidering Ebvallo after a prior rejection, following an agreement with the companies developing the treatment to address the agency’s main concern.

Johnson & Johnson says its investigational OTTAVA robotic surgical system met primary safety and performance endpoints in a 30-patient gastric-bypass study.

An FDA advisory committee voted 6-3 against the clinical meaningfulness of results from a late-stage AstraZeneca trial, pushing back on what was described as a proposed new paradigm.

Amgen has filed a supplement to update the Tavneos label with additional warning information as the FDA continues pushing to withdraw the drug.

Axsome Therapeutics says the FDA has approved Auvelity for agitation associated with Alzheimer’s disease, a condition the company says affects up to 76% of patients.

The FDA has approved Pfizer and Arvinas’ vepdegestrant for a certain form of breast cancer, but the decision arrives with visible uncertainty about how broadly the drug will actually be used.

The FDA has approved Merck’s Idvynso, a once-daily two-drug tablet for certain adults with HIV-1, adding a new oral option for people who are already virologically suppressed.

A new FDA effort aims to use AI and real-time monitoring to reduce delays between clinical trial phases and compress parts of the drug development timeline.

The FDA has launched a pilot to review clinical trial data as it is generated, giving agency scientists earlier access to information from ongoing studies.

The U.S. FDA has approved Regeneron’s Otarmeni, the first gene therapy cleared for hearing loss caused by OTOF mutations, marking a major milestone for genetic medicine and auditory research.