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.  | After a site visit by FDA ...

Contract manufacturing powerhouse Lonza is growing in more ways than one. | Contract manufacturing powerhouse Lonza is growing in more ways than one. The Swiss company revealed this week that it is ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key ...

With the FDA approval for Tregzi, Orca Bio has become one of the very few U.S.-based commercial drugmaker that remains privately held. (Getty Images) Orca Bio has jumped into the commercial market ...

To help BridgeBio ramp up for the launch of three new medicines, plus approved ATTR-CM med Attruby, Sixth Street and HealthCare Royalty have agreed to invest up to $1 billion in the California biotech ...

Consumer health giant Haleon has tapped Microsoft to incorporate AI across its operations, joining a growing wave of healthcare and life sciences heavyweights turning to Big Tech ...

Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares are among the seven ...

A Brukinsa regimen has delivered a large progression-free survival (PFS) benefit in what BeOne Medicines called a “new ...

Despite a recent failure as a second-line monotherapy in diffuse B-cell lymphoma (DLBLC), a positive phase 3 combination ...

Viridian Therapeutics has scored an FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with ...

The FDA has issued a complete response letter to Unicycive over the “same third-party manufacturing deficiencies that were ...

Klick Health has struck its third takeover in 18 months, snapping up Oxford PharmaGenesis to expand its global reach and ...