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While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.

Daiichi Sankyo’s full-year report was originally scheduled for April 27 but has now been pushed back to May 11. That same day, the pharma expects to release its five-year business plan.

Pfizer’s decision to cut its early-stage cancer asset was due to “strategic business reasons” and not driven by safety or efficacy concerns.

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.

Of the 17 companies that were implored by the White House last July to apply Most Favored Nation pricing to their drugs, Regeneron is the last to agree—the same day the FDA greenlit its gene therapy for hearing loss in kids.

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.

The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.

Chief Scientific Officer Pedro Beltran will succeed Eli Wallace as CEO of BridgeBio Oncology Therapeutics, as the board eyes a busy period of clinical advancement in the RAS oncology space.

Sanofi’s interim leadership sought on a Thursday earnings call to quell concerns that its sudden defense of Dupixent’s patents had anything to do with the departure of CEO Paul Hudson.

• 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.