Industry News

Pharmaceutical Industry News

The FDA unveiled a new pilot…

October 3rd, 2025|Fierce Pharma|

The FDA unveiled a new pilot program that aims to speed up review times for generic drugmakers who test and manufacture their products in the U.S. Separately, the agency met with industry stakeholders this week

In a letter inked to the U.K.’s…

October 3rd, 2025|Fierce Pharma|

In a letter inked to the U.K.’s Competition and Markets Authority, three advocacy organizations called the recent string of Big Pharma companies pulling their U.K. investments a coordinated scheme for "anti-competitive purposes."

The FDA has approved Jazz…

October 3rd, 2025|Fierce Pharma|

The FDA has approved Jazz Pharmaceuticals’ Zepzelca, used in combination with Roche’s Tecentriq, as a first-line maintenance treatment in extensive-stage small cell lung cancer

The initial part of the up-to-$339…

October 3rd, 2025|Fierce Pharma|

The initial part of the up-to-$339 million funding will largely be used to establish U.S. manufacturing for the non-vaccine flu preventive candidate, with additional options tied to further clinical studies, Cidara said.

GSK has successfully appealed…

October 3rd, 2025|Fierce Pharma|

GSK has successfully appealed a ruling by the U.K. marketing watchdog that determined a trio of its COVID-19 vaccine press releases had brought discredit on the pharma industry.

Sealed court documents obtained by…

October 2nd, 2025|Fierce Pharma|

Sealed court documents obtained by Fierce Biotech reveal how Novo Nordisk and Singapore's KBP Biosciences went from partners in a $1.3 billion deal to legal foes. Takeda has decided to cease all research work in

Artificial intelligence is…

October 2nd, 2025|Fierce Pharma|

Artificial intelligence is redefining industries at an unprecedented pace—and healthcare is no exception. But as algorithms grow smarter and adoption accelerates, leaders face a pressing question: how do we embrace the possibilities of AI without

Vaxcyte is paying Thermo Fisher…

October 2nd, 2025|Fierce Pharma|

Vaxcyte is paying Thermo Fisher Scientific up to $1 billion to access vaccine fill-finish capacity at the CDMO’s production facility in Greenville, North Carolina. Vaxcyte positioned the deal as a “long-term U.S. commercial manufacturing commitment.”

The FDA agreed to re-review…

October 2nd, 2025|Fierce Pharma|

The FDA agreed to re-review Vanda's previously rejected bid to market its Hetlioz in jet lag disorder, which has been the center of a years-long legal dispute between the two.

In the phase 3 Vesalius-CV study,…

October 2nd, 2025|Fierce Pharma|

In the phase 3 Vesalius-CV study, Repatha helped significantly curb the risk of major adverse cardiovascular events over standard treatment alone in people who hadn’t had a heart attack or stroke before, Amgen announced.

BeOne Medicines and AbbVie have…

October 2nd, 2025|Fierce Pharma|

BeOne Medicines and AbbVie have decided to voluntarily dismiss the patent lawsuit the Big Pharma firm brought against its competitor over their BTK inhibitors.