dermatologyadvisor

FDA Adds Brain Tumor Warning to Depo-Provera Birth Control Shot

More than 1000 women sued Pfizer due to the meningioma risks, which the FDA originally declined to add to the label in 2024. HealthDay News — The U.S. Food and Drug Administration (FDA) approved a new ...
LGBTQ Nation

FDA threatens companies selling binders: They want to “control every ounce of trans people’s lives”

Following the announcement from the Department of Health and Human Services (HHS) of new rules that would end gender-affirming care for minors, the Food and Drug Administration (FDA) threatened ...
Medical Design and Outsourcing

Listening, learning and leading won FDA de novo classification for Peytant

Bringing a truly novel medical device to market is not for the faint of heart. The FDA’s de novo classification process, designed for low- to moderate-risk devices without a predicate, offers enormous ...
Seeking Alpha

TScan Therapeutics Reaches Agreement with FDA on Pivotal Study Design for TSC-101 and Announces Strategic Prioritization to Advance TSC-101 and Extend Cash Runway into H2 2027

Dosed first solid tumor patients with multiplex TCR-T therapy; paused further enrollment to prioritize heme development; reiterates planned data readout in Q1 2026 Enacted ~30% workforce reduction to ...
Health.com

FDA Announces Nationwide Recall of Birth Control Pills—Nearly 27,000 Packs Affected

Nick Blackmer is a librarian, fact-checker, and researcher with more than 20 years of experience in consumer-facing health and wellness content. Glenmark Pharmaceuticals recalled almost 27,000 packs ...
MedPage Today

FDA Slaps Boxed Warning on Bleeding Control Drug

The FDA is requiring stronger warnings for tranexamic acid (TXA) injection to avoid medication errors following reports of serious injury, including death. "FDA is ...
Targeted Oncology

Defining Survival: FDA's New Requirements for Oncology Trial Design

FDA's new guidance clarifies overall survival data collection in clinical trials, emphasizing long-term follow-up, subgroup analysis, and trial design considerations. Harpreet Singh, MD, former ...
MD&M East

A Complete Guide to Medical Device Design and Development

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...
MD&M East

Medtronic Secures FDA Approval for Ankle-Implanted Device to Treat Urinary Incontinence

Medtronic said it has won an FDA nod for an implantable tibial neuromodulation therapy that treats urge urinary incontinence. The Altaviva device is inserted near the ankle. The Dublin-based company ...
Fast Company

Tesla’s door handles are dangerous. They might finally be getting a redesign

Tesla’s door handle design is notoriously terrible, unintuitive, and dangerous. Customers have been saying it for years. After multiple damning reports, the company might finally be doing something ...
JD Supra

Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices

On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...
Seeking Alpha

Rezolute Announces Alignment with FDA on Streamlined Design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism

REDWOOD CITY, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by ...