Industry News

Pharmaceutical Industry News

Roughly half a year after…

December 10th, 2025|Fierce Pharma|

Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher pilot review program. The inaugural approval under the program has gone

Supreme Group has consolidated two…

December 10th, 2025|Fierce Pharma|

Supreme Group has consolidated two of the companies it bought during a nine-deal, 18-month splurge, combining Amendola Communications and Health+Commerce to form a PR and communications agency.

Pfizer has rolled out detailed…

December 9th, 2025|Fierce Pharma|

Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.

Eli Lilly has unveiled the…

December 9th, 2025|Fierce Pharma|

Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities planned for the U.S. The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will

With a new edition of a…

December 9th, 2025|Fierce Pharma|

With a new edition of a long-running awareness campaign, Genentech is drawing attention to the talents and passions that are helping people with multiple sclerosis thrive.

Bora and Corealis are joining…

December 9th, 2025|Fierce Pharma|

Bora and Corealis are joining forces to create a new end-to-end CDMO offering for oral solid dose drug development and production. The strategic alliance will be designed to simplify the drug development process and offer

Returning its stake in Biocon…

December 9th, 2025|Fierce Pharma|

Returning its stake in Biocon Biologics allows Viatris to re-enter the biosimilar market it left as a result of its 2022 transaction with Biocon.

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.