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TOP STORIES
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.
Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities.
In this episode of Denatured, you’ll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder and Chief Medical Officer of Calluna Pharma. We dive into IPF and fibrosis challenges, unpacking treatment hurdles, emerging targets, unmet needs and expansion paths beyond the lung.
Panel interviews can play a major role in getting jobs. Two career coaches discuss what to do before and during the interview, including identifying how to differentiate yourself, engaging in true conversations and not overlooking a key panel member.
Biotech R&D job postings live on BioSpace rose for the fourth straight month in April, and a CBRE report shared similar findings for employment. The head of CBRE’s U.S. life sciences practice discusses what’s behind the growth and the current job market.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
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