The department is funding innovative trial proposals and weighing an end to the traditional phased clinical trial system to keep pace with foreign competition,

The watered-down Global Benchmark rule for doctor-administered drugs applies to only four companies, sharply limiting expected savings on Medicare drug prices.

Complete late-stage results for Lilly's next-generation obesity drug intensify competition in the weight loss market.

The two companies will develop long-acting antibody drugs against the same targets as their blockbuster anti-inflammation agent Dupixent.

Reporters traveled to Shanghai to examine China's rapid biotech rise and its growing competition with the U.S. industry.

Durability questions about the experimental Huntington's therapy matter to Wall Street but weigh less on patients, as analysts upgraded shares.

A limited number of liver-related safety events, including a patient death, were reported in testing of Bristol Myers' admilparant.

The approval marks the first targeted treatment for the rare thyroid hormone transport disorder MCT8 deficiency.

Premiums hold steady but plans are raising deductibles and trimming benefits, making care more expensive for beneficiaries.

Positive late-stage melanoma data from a personalized mRNA vaccine renewed investor interest in the platform.

Lyrfigtu becomes the first targeted FGFR2 inhibitor cleared for advanced bile duct cancer.

The breakthrough designation covers a pancreatic cancer drug reported to nearly double survival in advanced disease.

The FDA had not previously accepted an application of a BTK inhibitor drug for two major forms of MS, though safety questions remain.

The scientific meeting featured data from Lilly, Novo Nordisk and contenders from AbbVie and Boehringer in the obesity field.

The clearance is the first approved therapy for Sanfilippo syndrome type A, a rare and fatal pediatric neurodegenerative disease.

The downgrade follows a sharp run-up in Moderna shares tied to cancer vaccine enthusiasm, with the stock falling before later rebounding.

Cantor takes over the drug industry lobby as it confronts bipartisan backlash over rising health care costs.

The new pilot offers sponsors a faster review pathway, with implications for how drugs reach the market.