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Stealth BioTherapeutics' chief executive Reenie McCarthy

Axe falls on Stealth Bio staff after FDA rejects lead drug

Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.

News

MSD and Daiichi Sankyo pull HER3-DXd's FDA filing

MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.

News

FDA tightens heart tox warnings on mRNA COVID vaccines

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.

News

Mixed outcomes for pharma in big week for FDA adcomms

There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer.

News

US imposes limits on COVID-19 boosters and new jabs

The FDA has introduced a stricter set of policies around COVID-19 vaccines, including requiring clinical trials for new shots in some cases.

Digital

Eric Luellen and Jonah Comstock interview at AAPS

AI-powered drug discovery is outpacing regulators, with Eric...

During the AAPS National Biotech Conference 2025, pharmaphorum’s Jonah Comstock sat down with Eric Luellen, the founder and CTIO of Turing Biosciences

Axe falls on Stealth Bio staff after FDA rejects lead drug

MSD and Daiichi Sankyo pull HER3-DXd's FDA filing

FDA tightens heart tox warnings on mRNA COVID vaccines

Mixed outcomes for pharma in big week for FDA adcomms

US imposes limits on COVID-19 boosters and new jabs

AI-powered drug discovery is outpacing regulators, with Eric...

Lilly bags FDA okay for Wegovy pill rival orforglipron

Using AI-driven synthetic personas to take your insights fur...

FDA

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