BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use

By Tyler Menichiello, Chief Editor, Bioprocess Online June 16 marked the beginning of this year’s BIO International Convention in Boston — a multiday gathering of the brightest minds and stakeholders from across the biotech world. Founders, CEOs, CSOs, …

Belimumab Autoinjector Receives FDA Approval for Children With Active Lupus Nephritis

The FDA approved an autoinjector of belimumab (Benlysta; GSK) for the subcutaneous injection in children aged 5 years and older with active lupus nephritis (LN) who are receiving standard therapy. This 200 mg/mL autoinjector was also approved for …

FDA hires former FDA scientist Michael Davis as CDER deputy director

Sources: FDA chief Makary sought rejection of KalVista's drug

Top FDA drug regulator to retire, adding to long list of agency departures

The top drug regulator at the Food and Drug Administration announced Wednesday that she’s retiring in July. Her departure is the latest in a series of top leaders leaving the FDA since President Trump took office. Lizzy Lawrence, FDA reporter at STAT, …

FDA approves biannual HIV prevention shot

Device that uses biodegradable polymers to repair peripheral nerves gets FDA clearance

“This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really …

STAT+: Radical transparency at the FDA, and a pivotal moment for vaccines

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Health, faith-based, and anti-hunger organizations …

Archeus Technologies Gets FDA Clearance for ART-101 Prostate Cancer Trial

Archeus Technologies announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment …

Gland Pharma facility in Vizag recieves EIR from U.S. FDA

Gland Pharma’s facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment inspection report from the agency, the generic injectable focussed …