Fiercepharma.com

President Donald Trump has approved a plan to fire FDA Commissioner Marty Makary, M.D., according to a report from The Wall Street Journal.

During the weeklong stay by the Supreme Court to temporarily restore online access to the abortion pill mifepristone after a shock appeals court decision last Friday, scores of experts, industry heavyweights and former regulators have weighed in to defend the availability of the product.

Explore how targeted protein degradation is reshaping drug discovery, enabling new approaches for difficult targets and advancing novel therapeutic modalities.

Gilead raised its previous guidance of $800 million in revenues from the long-acting PrEP injectable Yeztugo based on a high-flying launch thus far.

With an FDA decision date looming for its Duchenne muscular dystrophy (DMD) treatment deramiocel, Capricor Therapeutics has filed a lawsuit against its U.S. commercial partner, NS Pharma, and its parent company, Nippon Shinyaku.

Daiichi Sankyo is poised to report significantly lower full-year profit for fiscal year 2025, primarily due to a $610 million hit linked to its precautionary antibody-drug conjugate manufacturing strategy.

Fierce Pharma’s Fraiser Kansteiner catches up with KPMG’s Chris Young to discuss the latest pharma tariff developments and how Big Pharma and small- to mid-sized drugmakers are responding.

Summit's PD-1xVEGF study surprisingly missed its mark at an interim analysis. UCB will pay $2 billion upfront to buy Candid Therapeutics, which has aggregated a group of Chinese assets. J&J eliminated two CD20 CAR-T programs that it licensed from Sino-American biotech AbelZeta. And more.

With an eye on the lucrative U.S. market, Italy’s Angelini Pharma will acquire rare disease specialist Catalyst Pharmaceuticals and its potential blockbuster Firdapse for $4.1 billion.

After a surprise rejection in January, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. The case could reignite investors’ hope of a potential reversal for uniQure's high-profile gene therapy, too.