Industry News

Pharmaceutical Industry News

Boehringer’s Jascayd can now crack…

December 22nd, 2025|Fierce Pharma|

Boehringer's Jascayd can now crack open the rare progressive pulmonary fibrosis disease market just two months after its initial market entry in idiopathic pulmonary fibrosis.

Slated for a Dec. 26 decision on…

December 22nd, 2025|Fierce Pharma|

Slated for a Dec. 26 decision on Cytokinetics’ aficamten, the FDA has delivered an early Christmas present, awarding the biotech its first U.S. nod since it was established in 1997. The agency has signed off

A six-month community awareness…

December 22nd, 2025|Fierce Pharma|

A six-month community awareness campaign has significantly increased colorectal cancer awareness in part of Nigeria, leading researchers to recommend expanding the model to the national level.

The acquisition will allow…

December 22nd, 2025|Fierce Pharma|

The acquisition will allow Shionogi to add a "strong rare disease commercial platform in the U.S. market," potentially supporting its planned launches in Fragile X syndrome, Jordan’s Syndrome and Pompe disease, the company said.

The approval for Lunsumio Velo…

December 22nd, 2025|Fierce Pharma|

The approval for Lunsumio Velo allows Roche to fill an administration convenience gap with AbbVie and Genmab's rival T-cell engager; all the while, the Swiss pharma has been touting the reduced burden of its fixed-duration

Incog BioPharma, a sterile…

December 22nd, 2025|Fierce Pharma|

Incog BioPharma, a sterile injectables CDMO, plans to shell out about $200 million to boost production capacity at its Fishers, Indiana, manufacturing site.

Samsung Bio’s U.S. subsidiary…

December 22nd, 2025|Fierce Pharma|

Samsung Bio’s U.S. subsidiary will pay $280 million to acquire GSK’s Human Genome Sciences and its two pharmaceutical manufacturing plants at a campus in Rockville, Maryland. The site, which will mark Samsung Bio’s first for

Updates on DTC advertising and DTP…

December 19th, 2025|Fierce Pharma|

Updates on DTC advertising and DTP programs, as well as special reports, event coverage and, of course, news bulletins from the ever-evolving GLP-1 front all made the list of our most-read stories in 2025.

After a series of ownership…

December 19th, 2025|Fierce Pharma|

After a series of ownership changes, Andexxa is slated to be pulled from the market in the coming days. The FDA said it "considers the risks of the product to outweigh its benefits."

The Elevidys-related manufacturing…

December 19th, 2025|Fierce Pharma|

The Elevidys-related manufacturing shortfalls were described in one of two Form 483s tied to FDA inspections that came before Catalent's layoff spree at its Maryland gene therapy manufacturing business.

Sixteen months after luring former…

December 19th, 2025|Fierce Pharma|

Sixteen months after luring former Roche dealmaker James Sabry, M.D., Ph.D., out of retirement and signaling a shift in its business development approach, BioMarin has announced the largest transaction in the company’s 28-year history.

Amgen, Boehringer Ingelheim,…

December 19th, 2025|Fierce Pharma|

Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, GSK, Merck & Co., Novartis, Roche and Sanofi have agreed with the White House to reduce the prices of certain prescription medicines in exchange for pharmaceutical tariff

As the FDA steadily churns out a…

December 19th, 2025|Fierce Pharma|

As the FDA steadily churns out a stream of untitled letters chastising pharmaceutical advertisers’ direct-to-consumer materials, a commercial for Bristol Myers Squibb’s Cobenfy is taking its turn in the hot seat.

Cybin is shedding its old…

December 19th, 2025|Fierce Pharma|

Cybin is shedding its old identity, evolving into Helus Pharma as part of changes that will see its shares move to a different stock exchange.

Alvotech and Teva’s Eylea…

December 19th, 2025|Fierce Pharma|

Alvotech and Teva's Eylea biosimilar has been under FDA review for much of this year. Back in February, the companies said they expected a decision by the end of 2025.

Pharma marketers enter 2026 asking…

December 19th, 2025|Fierce Pharma|

Pharma marketers enter 2026 asking where DTC fits in the DTP era. That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient programs. The programs are changing how patients access medicines—and