Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as ...

Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new ...

President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless ...

In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that ...

Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and ...

BML Capital Management, an activist investor that owns 9.9% of Elevation’s shares, is urging the company to wind down ...

Alis Biosciences’ plan is a familiar tactic in the private equity world, but the firm will instead be listed on the public ...

Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory ...

Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; ...

With tariffs pushing manufacturing home to the U.S., Pitchbook warns of reduced M&A activity and venture capital funding.

Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a ...

Despite these cuts, the FDA should be able to stay above a "trigger" level that would prevent it from collecting fees from ...