Industry News

Pharmaceutical Industry News

Pfizer has unveiled phase 3…

December 5th, 2025|Fierce Pharma|

Pfizer has unveiled phase 3 results that could help the company’s hemophilia drug Hympavzi level the playing field in its competition with Sanofi’s Qfitlia and Novo Nordisk’s Alhemo.

With FDA approval to treat…

December 5th, 2025|Fierce Pharma|

With FDA approval to treat marginal zone lymphoma, Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for five different types

Halozyme is seeing some progress…

December 5th, 2025|Fierce Pharma|

Halozyme is seeing some progress in its global effort to defend intellectual property against alleged infringement by Merck & Co.'s new version of Keytruda. A court in Germany ordered the pharma giant to halt Keytruda

The FDA is investigating a safety…

December 5th, 2025|Fierce Pharma|

The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi Sankyo won reversal of an unfavorable ruling in

Avalere Health has hired Sarah…

December 5th, 2025|Fierce Pharma|

Avalere Health has hired Sarah Hall as president of U.S. marketing, tapping the direct-to-consumer expert to lead its team through a “politically dynamic” period.

Regeneron is taking a simplified…

December 4th, 2025|Fierce Pharma|

Regeneron is taking a simplified approach in its bid to move T-cell engagers Lynozyfic and Ordspono into earlier lines of blood cancer treatment by trying to offer less onerous regimens for patients.

The latest untitled letter from…

December 4th, 2025|Fierce Pharma|

The latest untitled letter from the FDA’s Office of Prescription Drug Promotion zeroes in on a patient testimonial video about Daiichi Sankyo’s tenosynovial giant cell tumor treatment Turalio.

Theresa Michele, the director of…

December 4th, 2025|Fierce Pharma|

Theresa Michele, the director of the Office of Nonprescription Drugs for a decade, has been transferred to another agency role, Fierce Pharma has learned.

Drastic overhauls of U.S. vaccine…

December 4th, 2025|Fierce Pharma|

Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.

The Buckland Group launched Quvara…

December 4th, 2025|Fierce Pharma|

The Buckland Group launched Quvara Medical as the newest CDMO to debut this year after buying a former Becton Dickinson manufacturing site in the U.K. for an undisclosed price.

China biopharma contracting…

December 4th, 2025|Fierce Pharma|

China biopharma contracting juggernaut WuXi AppTec faces a new threat that its extensive business ties to the U.S. could be imperiled as the Pentagon has identified the company as one of eight that assist the

Cosmo Pharmaceuticals has revealed…

December 3rd, 2025|Fierce Pharma|

Cosmo Pharmaceuticals has revealed topline results from two phase 3 trials which indicate that its topical cream clascoterone could become a game-changing treatment for male-pattern hair loss.

A federal appeals court has…

December 3rd, 2025|Fierce Pharma|

A federal appeals court has overturned a previous ruling out of Texas that required Daiichi to pay $41.8 million in Enhertu royalties, plus an 8% running royalty rate, to its former ADC partner, Seagen.