Changes to the Regulatory Landscape, and what they mean.

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FDA Approves First mRNA Flu Vaccine, Moderna’s mFLUSIVA

FDA licensed mFLUSIVA for adults 50 and older on 5 August 2026 — a standard approval for ages 50–64 and an accelerated approval for 65 and up, pending a confirmatory trial. The clearance follows a February refusal-to-file that Moderna disputed and FDA reversed within two weeks.

By Connor Griggs5 August 20266 min read

Devices

FDA Clears BlueWind’s Revi Extend Bladder Implant

The 510(k) clearance covers a next-generation version of BlueWind's tibial neuromodulation implant for urgency urinary incontinence, extending device life to 15 years and leaning on three-year data from the pivotal OASIS trial. A limited US launch is planned for the fourth quarter.

5 August 20265 min read

Clinical

MHRA’s ILAP Passports Go to Liver Cancer, Dementia Drugs

The UK's Innovative Licensing and Access Pathway has granted Innovation Passports to CervoMed's neflamapimod, for dementia with Lewy bodies, and BeOne Medicines' BGB-B2033, a bispecific antibody for hepatocellular carcinoma. The announcement lands the same day ILAP's next application round opens.

4 August 20265 min read

Devices

FDA Classifies Ventilator, Heart-Pump Recalls as Class I

Corrections to ResMed’s Astral ventilators and Abiomed’s Impella introducer kits both drew FDA’s most serious recall classification this week — the second Impella-line introducer action in six weeks. Neither device is leaving the market; both corrections stay open in hospitals under revised instructions.

3 August 20265 min read

FDA

FDA Reopens Comment Period on Title 21 Terminology Rule

A proposed rule that would strip the word “gender” from Title 21 of the Code of Federal Regulations — replacing it with “sex” or deleting the reference — gets sixty more days of public comment. FDA says the rule implements a January 2025 executive order; the docket now closes October 2.

3 August 20264 min read

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Showing 32 of 32 stories

The dome of the U.S. Capitol rises against a clear blue sky, an American flag flying from its balustrade FDA FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA Aug 5, 20266 min read Read the story Two researchers in cleanroom coveralls, hairnets and masks review data on a computer monitor in a lab Devices FDA Clears BlueWind's Revi Extend Bladder Implant Aug 5, 20265 min read Read the story A gloved researcher holds a pipette over a sample tube while a colleague looks on in a laboratory Clinical MHRA's ILAP Passports Go to Liver Cancer, Dementia Drugs Aug 4, 20265 min read Read the story A gloved researcher adjusts the lens turret of a laboratory microscope during a bench inspection Devices FDA Classifies Ventilator, Heart-Pump Recalls as Class I Aug 3, 20265 min read Read the story A row of Corinthian columns rises along the stone facade of a government office building flying American flags FDA FDA Reopens Comment Period on Title 21 Terminology Rule Aug 3, 20264 min read Read the story Four small glass vials with red and blue caps scattered across a blue background Guidance FDA Drafts Rules for Biosimilar Autoinjectors, Syringes Aug 3, 20265 min read Read the story A researcher in a hairnet and lab coat looks through a benchtop microscope while adjusting its focus knob FDA FDA Debars Research Site Owners Who Faked Trial Data Aug 3, 20265 min read Read the story A person signs a printed document by hand with a pen while a colleague stands nearby at a wooden table FDA FDA Grants Breakthrough Status to Lilly's KRAS Drug Aug 3, 20264 min read Read the story Two researchers in a laboratory, one examining a sample under a microscope while a colleague works at a fume hood in the background FDA FDA Panel Votes 9-3 Against Capricor's DMD Heart Drug Aug 2, 20266 min read Read the story A gloved hand lifts a glass vial from a row of vials on a laboratory bench, its label left blank FDA FDA Licenses the First Freeze-Dried Plasma for the US Aug 2, 20265 min read Read the story An assortment of pharmaceutical blister packs holding pills and capsules of varying colors spread across a white surface Guidance FDA Finalizes Adhesion Rules for Generic Skin Patches Aug 2, 20265 min read Read the story A loose pile of white, oblong pharmaceutical tablets spread across a light blue background Guidance FDA Finalizes Three Cancer Trial Eligibility Guidances Jul 30, 20265 min read Read the story Loose orange, pink, and yellow tablets scattered across a light gray surface, softly out of focus Devices MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story A gloved hand lifts a rack of purple-capped sample collection tubes at a testing table, with a rapid-test box in the background Devices FDA Gives Home COVID Tests a Permanent Class II Address Jul 27, 20265 min read Read the story Two colleagues review a printed self-injection instruction sheet next to an open laptop FDA FDA Approves MannKind's 10-Second Heart-Failure Autoinjector Jul 27, 20265 min read Read the story A gloved hand adjusts the focus stage of a laboratory microscope holding a slide Clinical CHMP Rejects Arimoclomol Again; Zevra Seeks Re-Examination Jul 27, 20266 min read Read the story A researcher wearing glasses looks through a binocular microscope while a colleague in a lab coat stands in the background FDA FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug Jul 26, 20266 min read Read the story A gloved hand reaches for a rack of blood sample tubes with pink caps on a laboratory bench Clinical CHMP Backs the EU's First Refillable Eye Implant Jul 26, 20266 min read Read the story Blister packs holding rows of blue, yellow, white, and pink tablets, viewed close up on a wooden table Manufacturing FDA Publishes Its Playbook for Fast-Track CMC Readiness Jul 26, 20265 min read Read the story A person in a dark jacket signs printed documents at a wooden desk while colleagues stand nearby Sponsored Inside the Free 510(k) Course Built From the Primary Record Jul 26, 20264 min read Read the story Three men in business suits stand at a lectern with a U.S. flag behind them, one gesturing as he speaks Devices FDA Picks Dexcom as First TEMPO Pilot Participant Jul 24, 20266 min read Read the story A woman in a lilac blazer speaks into a microphone while reading from a paper at a wooden lectern Manufacturing MHRA Approves the World's First Low-Carbon Asthma Inhaler Jul 24, 20265 min read Read the story A woman in glasses smiles while speaking at a lectern beside a European Union flag, addressing seated attendees EU MDR & IVDR Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story A scientist at FDA's Center for Biologics Evaluation and Research examining a cell-culture flask under an inverted microscope FDA FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story Buildings 1 and 21 at the entrance to the FDA's White Oak campus, with the Maryland and agency flags flying FDA FDA Can Now Ask the Public for OTC Monograph Data Jul 17, 20265 min read Read the story Gloved hands loading sample tubes into a benchtop centrifuge in an FDA laboratory Guidance FDA Retires a 1995 Guidance on Topical Steroids Jul 17, 20265 min read Read the story FDA Building 66, home of the Center for Devices and Radiological Health Devices MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story Rows of empty seats facing an FDA-branded screen in the White Oak Great Room FDA FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story A scientist working at a cabinet in an FDA laboratory FDA FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story A gloved hand holding a tablet over dissolution-testing equipment in an FDA laboratory Guidance FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story The Food and Drug Administration sign above the entrance to the agency's headquarters FDA FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story The hemicycle of the European Parliament in Brussels EU MDR & IVDR EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story

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