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Pharmaceutical Industry News

As an FDA official said that the…

December 9th, 2025|Fierce Pharma|

As an FDA official said that the agency has evidence that links COVID vaccines to the deaths of at least 10 children, the U.S. regulator also is examining the safety of shots that protect infants

Over the weekend, the Senate and…

December 9th, 2025|Fierce Pharma|

Over the weekend, the Senate and House released the final text of the National Defense Authorization Act for the 2026 fiscal year, tucking in language that would significantly stymie the ability of certain Chinese life

CSL, which earlier this year…

December 9th, 2025|Fierce Pharma|

CSL, which earlier this year shelved plans to put its CSL Seqirus vaccine division up for sale, has opened the doors to a new $1 billion cell-based flu shot and antivenom facility in Melbourne.

A proposed combination of Johnson…

December 8th, 2025|Fierce Pharma|

A proposed combination of Johnson & Johnson’s multiple myeloma bispecific Tecvayli has turned up positive trial data that could put some pressure on CAR T-cell therapies, including the company’s own Carvykti.

Transformed Gamida Cell has scored…

December 8th, 2025|Fierce Pharma|

Transformed Gamida Cell has scored an expansion for Omisirge, with the FDA endorsing the cell therapy to treat severe aplastic anemia. The approval comes more than two years after Omisirge’s original FDA nod as the

Despite holding positive phase 3…

December 8th, 2025|Fierce Pharma|

Despite holding positive phase 3 data that position its BTK inhibitor Jaypirca for a first-line approval in chronic lymphocytic leukemia, Jacob Van Naarden, president of Lilly Oncology, maintained that the drug’s primary value proposition remains

China’s National Healthcare…

December 8th, 2025|Fierce Pharma|

China's National Healthcare Security Administration unveiled its first batch of 19 meds selected for its new Commercial Health Insurance Innovative Drug Catalogue.

UCB plans to file for regulatory…

December 8th, 2025|Fierce Pharma|

UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare

After five years of follow-up on…

December 5th, 2025|Fierce Pharma|

After five years of follow-up on its hemophilia B gene therapy Hemgenix, CSL found that a one-time dose cut down on annualized bleeding rates by 90% by the fifth year in its Hope-B study.

Mark Cuban, the co-founder of…

December 5th, 2025|Fierce Pharma|

Mark Cuban, the co-founder of online pharmacy Cost Plus Drugs, says his company would produce generic drugs in the U.S. if the FDA eliminated approval fees.

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.