News

BioSpace2h
Banning Industry From FDA Adcomms Won’t ‘Move the Needle Much’ in Makary, RFK’s Fight Against COIs
Newly confirmed FDA commissioner Marty Makary last week announced a directive that would limit industry participation in the ...
BioSpace4h
Following Rejection, FDA Okays Sanofi/Regeneron’s Dupixent for Chronic Hives
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new ...
BioSpace4h
After Phase III Win, Lilly Promises to Manufacture Weight-Loss Pill in US
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless ...
BioSpace3hOpinion
Opinion: Regulatory and Economic Turmoil Is More Familiar in Other Countries
Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as ...
BioSpace3h
Tempest Cuts 80% of Staff While Considering Strategic Alternatives
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 ...
BioSpace5h
Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview
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 ...