Fierce Biotech
JPM26, Day 1: Lilly, Nvidia expand AI team-up; Takeda R&D head talks lack of deal announcements
The life sciences world is once again converging in San Francisco as the J.P. Morgan Healthcare Conference kicks off for 2026 ...
Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...
Targeted Oncology
For a Second Time, FDA Denies Approval of Tab-Cel in EBV+ PTLD
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Public Broadcasting Service (PBS)
FDA's new expedited drug program raises legal questions and concerns
The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...
BioSpace
Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing ...
TMCnet
Bio Usawa Receives Ghana FDA Approval for BioUcenta™
The Ghana FDA’s approval was granted following a rigorous, science-based regulatory review that referenced comprehensive data ...