Pfizer Inc. acquires Metsera, Inc., beating Novo Nordisk, for up to $86.25/share. Click for my analysis of the deal and what ...

The U.S. Department of Health and Human Services announced that the U.S. Food and Drug Administration is initiating the removal of broad “black ...

BridgeBio said Pfizer’s filing of a complaint with the NAD “is an attempt to bypass the FDA, the federal agency responsible for overseeing prescription drug advertising, and to challenge promotional ...

The U.S. FDA moves to remove black box warnings from hormone replacement therapy products used for menopause. Read more here.

Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his ...

Alberto Espay was not prepared for how his world would be upended when he published a study on the number of people who have died while taking new, high-profile Alzheimer’s drugs. Last October, the ...

After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more ...

Food and Drug Administration is preparing to speed up approvals for biosimilars, or generic versions of complex biological ...

The FDA's draft guidance is supposed to cut the cost and time-associated burden of biosimilar development, despite a mixed ...

Commissioner Marty Makary said the agency is asking drugmakers to remove the strict black box warnings, with the goal of encouraging more women to take them. Labels on the medicines currently list ...

The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary ...

The U.S. Food and Drug Administration is preparing to speed up approvals for biosimilars, or generic versions of complex ...