Jonathan Gardner

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A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.

The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.

The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.

Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.

According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.

The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.

The U.K. drugmakers added to a series of recent tie-ups with Chinese counterparts amid broader scrutiny of such transactions in the U.S.

The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.

Nearly two years after clinical setbacks cratered Q32’s stock price, new results showed hair growth improvements that surpassed investors’ expectations.