Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
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.
PRESS RELEASES
Received FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stage Strengthened balance sheet by extinguishing $32 million in debt Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant
Prestigious Late-Breaking Research Session Positions PH-762 as a Promising New PD-1 Directed Immunotherapy Candidate on March 28, 2026 at 3 PM (MDT)
• Human Organoid Data Supports the Therapeutic Rationale for INM-901 Program Ahead of Human Clinical Trials • Consistent Anti-Inflammatory Effects Demonstrate Translation from Animal Models to Three-Dimensional Human Brain Tissue Systems
This novel whole-body insulin-sensitizing approach is designed to address insulin resistance independent of weight loss
