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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.

• New patent application covers treatment-emergent immune signature related to ‘turning cold tumors hot’ and the activation of targeted cytotoxic cellular immune responses • Company to host conference call later in April 2026 to review new biomarker signature • Biomarker signature meets pharmacodynamic/response criteria established by FDA’s Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in OST-HER2’s Phase 2b trial in the prevention of delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma to support a BLA submission under FDA’s Accelerated Approval Program

Anticipated peptide reclassification could expand the addressable market for PharmaTher’s PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, strengthening its position in next-generation peptide delivery

Proven Med Tech Leader with an Established Track Record of Commercial Success and Optimizing Shareholder Value Leading to over $3.4 Billion in Successful Exits

Model Medicines’ antiviral intellectual property portfolio encompasses 15 patent families covering novel compositions of matter, multi-scaffold Markush chemistry, formulations, and broad-spectrum methods of use across RNA and DNA viruses

· New XSeed Labs team at Servier’s Paris-Saclay campus brings together AI and immunology expertise to advance next-generation biologics.