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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
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.
PRESS RELEASES
Treatment Phase for Lead Clinical Candidate PH-762 Dose Escalation Trial is Complete with Favorable Safety, Tolerability and Pathology Data 2025 Financings and Warrant Exercises Strengthen Balance Sheet with $23.7 Million in Net Proceeds, Extending Cash Runway into the First Half of 2027
· RIPPLE™ (Remote Induction of Pulsed Pressure Lateral to Energy) is a proprietary ultrasound-mediated delivery technology. · RIPPLE™ has been developed to enable efficient, redosable, targeted, and safe delivery of a diverse range of genetic medicines with broad tissue biodistribution, including skeletal, cardiac, and diaphragm muscles.
Live Presentation and Q&A: Monday, March 9, 2026 10 AM EDT CEO to Discuss INTASYL Platform and PH-762 Phase 1b Results
