BioSpace News Archive

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.

The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?

Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.

Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.

Ceralasertib is part of AstraZeneca’s ambitious plan to hit $80 billion in revenue by 2030.

The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.

The biotech, which has a deal with Eli Lilly worth as much as $1.1 billion, is developing two targeted radiopharmaceuticals from its miniprotein radioconjugate platform.

Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”

Jacobio discovered JAB-23E73, which is designed to treat several KRAS mutation subtypes, and is testing the therapy in multiple Phase I trials.