Changes to the Regulatory Landscape, and what they mean.

FDA Finalizes Potency Guidance for Cell, Gene Therapies

FDA has issued final guidance on Potency Assurance for Cellular and Gene Therapy Products, replacing its 2011 potency-testing standard with a risk-based strategy that runs from development through postmarket monitoring — and that leans hardest on the patient-specific, short-shelf-life products the old rules fit worst.

By Connor Griggs5 November 20265 min read

For Physicians

FDA5 Nov

FDA Accepts First Gene Therapy for Huntington’s

FDA accepted uniQure’s Biologics License Application for AMT-130 (ifezuntirgene inilparvovec) on 2 November 2026, granting Priority Review under the Accelerated Approval pathway with a target action date of 1 May 2027. It would be the first disease-modifying treatment ever approved for Huntington’s disease — but the trial data behind it have told three different stories in the past 14 months, and the newest one lost statistical significance.

5 November 202611 min read

Spotlight

Specific Biologics5 Nov

Specific Biologics Raises $35M for ALS Gene Editor

The Toronto company’s oversubscribed Series A, led by Hatteras Venture Partners, funds a first-in-human trial of Dualase, a two-site gene editor designed to erase the C9ORF72 repeat expansion behind the most common inherited form of ALS.

5 November 20266 min read

Drugs & Biologics

FDA5 Nov

FDA Tentatively Approves First Generic HIV-Prevention Shot

FDA gave tentative approval to Dr. Reddy's generic injectable lenacapavir on November 2, 2026 — the first generic version of Gilead's twice-yearly HIV-prevention shot cleared for the 120 lower-income countries covered by a royalty-free licensing deal, with a target price near $40 a year.

5 November 20265 min read

Devices & Diagnostics

FDA5 Nov

FDA Flags ButterflyBVM Resuscitators Over Bellows Holes

FDA issued an Early Alert on November 3, 2026 for Compact Medical's ButterflyBVM bag-valve-mask resuscitators, after a higher-than-expected rate of holes in the device's bellows raised the risk of inadequate ventilation. Nine lots are being pulled from use; twenty-two more stay in service only with a mandatory pre-use test and a backup device on hand.

5 November 20265 min read

Spotlight

Clearances, approvals, financings and launches — the companies getting the go-ahead.

All spotlights →

Specific Biologics

Specific Biologics Raises $35M for ALS Gene Editor

5 November 20266 min read

StimCardio Medical

StimCardio Closes $30M Series A for AFib Wearable

The Los Angeles company’s oversubscribed Series A, led by Metis MedTech, funds a pivotal study of Rhyvive — a wrist-worn device that pairs sensing with non-invasive nerve stimulation to keep atrial fibrillation from coming back after ablation — and prepares a first FDA submission.

5 November 20266 min read

OrthoPediatrics KIDS

OrthoPediatrics Wins FDA Clearance for Retrograde Femur Nail

The Warsaw, Indiana company's Pediatric Nailing Platform gains a retrograde femur design, 7 to 11 millimeters across, built on instrumentation already used in roughly 15,000 children, as OrthoPediatrics raises its 2026 revenue guidance to $270–273 million.

2 November 20267 min read