After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...

With several high-profile drugmakers already lining up for manufacturing space, Fujifilm Biotechnologies is on the cusp of ...

After several PD-1xVEGF competitors forged alliances with Big Pharma players, Summit Therapeutics, the frontrunner in this hot cancer drug field, is reportedly seeking its own deal. | After several PD ...

Just days after President Donald Trump was elected in November, AstraZeneca unvei | AstraZeneca CEO Pascal Soriot is plotting ...

China’s National Medical Products Administration (NMPA) has approved four new drugs developed by local biopharma companies, ...

The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages.

Generic and biosimilar specialist Sandoz is strengthening its footprint in Slovenia, pledging $440 million to set up a new ...

Another BCMA-targeted agent has arrived for the treatment of multiple myeloma. | After a delay, Regeneron’s BCMA-directed ...

After taking aim at the United States’ vaccine safety reporting system earlier this year, Robert F. Kennedy Jr. | After ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

Despite the popularity of generic and biosimilar drugs in Europe—the latter of which have struggled to catch on in the ...