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If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.

The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.

Eli Lilly’s latest manufacturing expansion will support production of obesity blockbusters and next-gen assets, while the new Lilly Lebanon Advanced Therapies site will take experimental genetic medicines from research to commercialization.

Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

With initial patients coming back for their second dose of Gilead’s twice-yearly PrEP injection, the pharma thinks the shot will hit $1 billion in sales this year, serving as “a cornerstone in Gilead’s revenue growth story.”

Before discontinuing the asset, Ascendis Pharma was studying onvapegleukin alfa in advanced or metastatic solid tumors, demonstrating a three- to four-month overall survival advantage over historical controls.

Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.

The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.

Catalyst Pharmaceuticals comes with a trio of approved drugs as Angelini Pharma expands its neuroscience offerings.

Gilead is laying off Arcellx employees in California and Maryland, with some cuts effective this year and the remainder happening in 2027.

Entrada Therapeutics saw a 2.36% dystrophin increase in patients treated with its oligonucleotide asset—a number that fell short of the company’s prior guidance of a double-digit improvement.

$30.0 million upfront with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants for cash Offering led by Nantahala Capital, with participation of healthcare-dedicated funds, including Broadfin Holdings, and participation from existing shareholder, Glen Taylor, and members of the Company’s board of directors and management Net proceeds extend anticipated cash runway into second half of 2027, beyond expected PMA submission; if milestone-linked warrants are exercised in full for cash, it is anticipated that the cash runway would extend well beyond first full year of commercialization

Management to host conference call at 8:00 AM Eastern time on Thursday, February 12, 2026

L7 Informatics CEO explains why the next wave of life sciences innovation depends on digital unified platforms that orchestrate workflows, contextualize data, and enable AI-actionable operations.