New generic drug for skin infections is approved by the FDA

Officials for the FDA have approved a generic drug for the treatment of canine and feline skin infections. Cefovecin Sodium for Injection is sponsored by Qilu Animal Health Products Co. in Shandong, China.1 Cefovecin Sodium for Injection is an …

FDA Skips Advisory Committee For Capricor's Duchenne Cell Therapy

Capricor Therapeutics Inc CAPR on Tuesday provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD)—associated …

AI Spine Assistant Software Tool Receives FDA Clearance

June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received FDA 510(K) clearance for its latest version, Version 3. This achievement marks a significant milestone in CoLumbo's commitment …

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 …

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 hires former FDA scientist Michael Davis as CDER deputy director

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

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 …