In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

Led by Brett Giroir and GSK’s ex-chief medical officer, Altesa is advancing a medicine that’s changed hands multiple times and once failed a study in asthma.

Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, ...

As the CGT market evolves, developers must answer one key question that will shape their manufacturing strategy: “Should we go with a modular platform or a fully integrated system?”  Both approaches ...

The potentially $4.4 billion deal is Madrigal’s second with a China-based biotech and hands the company six preclinical RNA ...

The HHS secretary has four new senior advisors to help him “move faster and go further” on his Make America Healthy Again agenda.

Shares of Evommune nearly doubled on data suggesting it has a potential threat to Dupixent. Elsewhere, a closely watched ...

Lyell’s trial will test its experimental cancer cell therapy directly against marketed counterparts. Elsewhere, Biogen swapped board chairs and venture firms are joining up at a “pivotal time” for ...

Another FDA knockback for a gene therapy has investors and analysts redrawing expectations for the rare disease drug developer.

Kailera CEO Ron Renaud claimed the weight loss effects and safety profile observed in the study suggest its therapy could ...

Shares of at least four other developers were up by mid-single digits to low-double digits at certain points on Tuesday.

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.