Fraiser Kansteiner

After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator.

As Bristol Myers Squibb attempts to convert two accelerated oncology nods for Krazati into traditional FDA approvals, the company has detailed a phase 3 flop in the KRAS G12C inhibitor's smaller-opportunity indication of colorectal cancer.

After pledging earlier this year to bolster its drug substance capabilities in Central Europe, German chemical company Evonik is turning its attention to the U.S.

On the heels of a European Commission probe into whether Sanofi “disparaged” one of its flu vaccine rivals in the marketing of its own shot, the EC is lining up a “market test” to solicit feedback on new promotional commitments offered up by the French pharma.

When launching a drug as big as semaglutide, even as a generic, the market expectations are immense, and any fumble on the part of the drugmaker can take a toll.

Aiming to streamline the compensation process for people claiming harm from COVID-19 vaccines, Robert F. Kennedy Jr.'s Department of Health and Human Services is gearing up to draft a list of injuries believed to be linked to the shots.

This week on "The Top Line," we're covering some of the biggest stories across biopharma before turning to one of the industry's major scientific meetings of the summer.

Even as the effort has met with fierce pushback from drugmakers, trade groups and opposition parties in the country's own government, German lawmakers late Friday voted to pass health insurance reforms aiming to cut healthcare costs next year, in part by hiking up mandatory rebates that pharmas must pay on branded medicines.

After speedrunning a series of major manufacturing milestones in the past year and a half, the “biotech floodgates” have opened for Cellares, the automated cell therapy manufacturing specialist's co-founder and CEO told Fierce Pharma Manufacturing.

With a midstage peek at the data on Veradermics' oral formulation of the molecule behind the ubiquitous hair regrowth treatment Rogaine, analysts