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MDLinx

Docs Call FDA Approval Without an RCT ‘Truly Bananas.’ What Precedent Does It Set for Evidence Standards?

“There are a lot of people with autism who don’t have a folate deficiency, and there are a lot of people with a folate deficiency who don’t have autism.” — Ben Rein, PhD

Neurology March 18th 2026

Tags: AUTISM SPECTRUM DISORDERS (ASD) DEVICE/DRUG APPROVALS REAL-WORLD EVIDENCE REGULATORY AFFAIRS

MDSpire News

FDA Expands HPV Primary Screening Options

The Aptima HPV assay uses messenger RNA detection to identify infections most likely to lead to cervical cancer.

Medical Oncology February 11th 2026

Tags: CANCER SCREENING CERVICAL CANCER FDA HPV REGULATORY AFFAIRS WOMEN'S HEALTH

Parkinson’s News Today

FDA Grants Advanced Therapy Status to Parkinson’s Cell Treatment

Twelve months after transplantation with the lower dose, mean scores decreased by 30.6 points during off time (a 52.82% improvement from baseline) and by 12.9 points during on time (a 54.67% improvement).

Geriatrics February 5th 2026

Tags: FDA MOVEMENT DISORDERS NEUROSURGERY PARKINSON'S DISEASE (PD) REGULATORY AFFAIRS

Oncology News Central (ONC)

FDA Delivers Second Rejection to CAR-T for Posttransplant Lymphoproliferative Disorder

“We are surprised and disappointed by this FDA decision for EBV+ PTLD patients who have a significant unmet need, highlighted by tabelecleucel’s orphan drug designation and by the granting of breakthrough status.” — Dr. Cokey Nguyen, Atara CEO

Hematology/Oncology January 20th 2026

Tags: CAR T-CELL THERAPIES DEVICE/DRUG APPROVALS RARE CONDITIONS & DISEASES REGULATORY AFFAIRS TRANSPLANT MEDICINE

MDLinx

Docs Say ‘The FDA is Failing Women’ When It Comes To This Much-Needed Therapy

“The FDA is failing women by denying access to a hormone their bodies naturally produce.” — Kelly Casperson, MD

Obstetrics & Gynecology January 13th 2026

Tags: FDA GENDER DISPARITIES HORMONAL HEALTH REGULATORY AFFAIRS TESTOSTERONE WOMEN'S HEALTH

MDSpire News

‘FDA Said Yes, Despite Inconclusive Evidence’

A device that restricts blood flow and is worn around the neck, that has not been shown to provide any clinical benefit, is being sold to vulnerable populations—including children as young as 13.

Emergency Medicine December 2nd 2025

Tags: BRAIN INJURY/CONCUSSION MEDICAL DEVICES PATIENT SAFETY REGULATORY AFFAIRS

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