A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing on how the agency’s bureaucracy affects innovation.

Less than six months after debuting as the first drug that can target a rare tumor type in patients with non-small cell lung cancer, Boehringer Ingelheim’s Hernexeos has quickly widened its reach into the first-line setting with the help of an FDA Commissioner’s National Priority Voucher (CNPV).

Following an unexpected delay of the CDC vaccine panel’s meeting originally planned for February, the Advisory Committee on Immunization Practices (ACIP) has selected dates next month to convene and discuss, among other matters, COVID-19 vaccine safety.

Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.

Sarepta Therapeutics CEO Doug Ingram announced Wednesday that he will retire by the end of 2026, citing a “shocking and ironic twist of fate” involving the health of his family.

With a new online resource, Eisai is offering patients and caregivers some direction to help navigate a kidney cancer diagnosis.