Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
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Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Non-Sedative Orexin Receptor Antagonist Proven Effective for Both Sleep Onset and Sleep Maintenance With No Meaningful Differences Between Dayvigo and Placebo on Next-Day Postural Stability or Memory and Improvement of Daily Functioning
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Kapoor was found guilty in May 2019 of orchestrating kickback schemes to encourage doctors to boost prescriptions of Subsys, a powerful pain killer.
Eisai Co., Ltd. has obtained the approvals of supplementary new drug applications in Japan for its in-house developed antiepileptic drug Fycompa for an additional indication for monotherapy of partial-onset seizures and an additional indication for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.
Coherus BioSciences, Inc. announced the Company has entered into a licensing agreement with Innovent Biologics, Co., Ltd.,, a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® in the United States and Canada.
The new coronavirus infection appears connected to a seafood market in Wuhan City in China, which has more a population of more than 11 million.
The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.