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Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.

After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”

Follow along as BioSpace tracks job cuts and restructuring initiatives.

The White House may have struck a deal with Eli Lilly and Novo Nordisk last week to lower the costs of their weight loss drugs for patients, but knockoff versions of Zepbound and Wegovy still permeate the obesity market.

Transformational quarter puts Envoy Medical in significantly better position as it eliminated $32 million of debt, strengthened its balance sheet, and further expanded its patent portfolio; In addition, subsequent to quarter end, the Company received FDA approval to expand its pivotal clinical trial to the final stage, restarted enrollment, and successfully raised additional capital