Newly confirmed FDA commissioner Marty Makary last week announced a directive that would limit industry participation in the ...

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 ...

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

California-based Tempest Therapeutics is laying off 21 of its 26 full-time employees. The cuts come while the biotech is exploring strategic alternatives, including a merger or acquisition, as it ...

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 ...

Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.

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

The raise will go toward trialing the company’s lead drug for phosphomannomutase-2 congenital disorder of glycosylation, a ...

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

Analysts are “cautiously optimistic” about Trump’s executive order, noting that changes to the IRA drug price negotiation ...