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Food and Drug Administration

Medicus Pharma
Regional

ICYMI: Medicus Narrows SkinJect Program to Gorlin Syndrome

September 27, 2026September 25, 2026 - by Timothy Alexander

PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) will end internally funded development of SkinJect for sporadic nodular basal cell carcinoma and concentrate its clinical spending on Gorlin syndrome, narrowing …

ICYMI: Medicus Narrows SkinJect Program to Gorlin Syndrome Read More

U.S. Food and Drug Administration
Health / Medical / National

FDA Approves First Treatment for Sanfilippo Syndrome Type A

September 21, 2026September 21, 2026 - by Timothy Alexander

WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Fayuvi, a one-time gene therapy from Ultragenyx Pharmaceutical Inc., as the first treatment for children with mucopolysaccharidosis type IIIA, providing …

FDA Approves First Treatment for Sanfilippo Syndrome Type A Read More
Food and Drug Administration
National / Research

FDA Opens Expedited Drug Trial Pilot to Cut Development Delays

September 21, 2026September 21, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration finalized an expedited regulatory pilot that will pair drug companies with qualified research institutions to shorten the path to first-in-human clinical …

FDA Opens Expedited Drug Trial Pilot to Cut Development Delays Read More

NRx Pharmaceuticals
Regional

NRx Gets Earlier FDA Goal Date for Ketamine Application

September 20, 2026September 19, 2026 - by Timothy Alexander

WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) received a revised Nov. 10 regulatory goal date for its preservative-free ketamine application after the U.S. Food and Drug Administration reclassified a …

NRx Gets Earlier FDA Goal Date for Ketamine Application Read More
Wave PRO
Expansions / New Markets

Pression Expands Coatesville Site as Heart Device Goes to Market

September 16, 2026September 15, 2026 - by Timothy Alexander

COATESVILLE, PA — Pression is more than doubling its Coatesville footprint as the medical-device startup moves its Wave PRO external counterpulsation system into manufacturing and sales following federal clearance, shifting …

Pression Expands Coatesville Site as Heart Device Goes to Market Read More

Prelude Therapeutics
Regional / Research

Prelude Wins FDA Clearance to Move Breast Cancer Drug to Trial

September 15, 2026September 13, 2026 - by Timothy Alexander

WILMINGTON, DE — Prelude Therapeutics Inc. (Nasdaq: PRLD) received U.S. Food and Drug Administration clearance to begin a Phase 1 trial of PRT13722, moving its experimental KAT6A-targeting breast cancer drug …

Prelude Wins FDA Clearance to Move Breast Cancer Drug to Trial Read More
AstraZeneca
Regional

FDA Clears AstraZeneca Breast Cancer Regimen on Early Detection

September 13, 2026September 12, 2026 - by Timothy Alexander

WILMINGTON, DE — AstraZeneca’s (NYSE: AZN) ETCAMAH (camizestrant) combination won accelerated U.S. approval for certain advanced breast cancer patients whose tumors develop an ESR1 mutation during first-line therapy, allowing treatment …

FDA Clears AstraZeneca Breast Cancer Regimen on Early Detection Read More

Medicus Pharma
Regional

FDA Clears Medicus SkinJect Study for Gorlin Syndrome

September 11, 2026September 10, 2026 - by Timothy Alexander

PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) received FDA authorization to begin an NDA-enabling Phase 2b study of SkinJect in patients with Gorlin Syndrome, advancing the company’s lead program …

FDA Clears Medicus SkinJect Study for Gorlin Syndrome Read More
Psych Congress
Health / Medical

Psych Congress Expands Psychedelics Focus as Policy Shifts

September 10, 2026September 7, 2026 - by Timothy Alexander

MALVERN, PA — Psych Congress 2026 will devote five days of programming Sept. 15-19 in New Orleans to psychedelic therapies as federal policy, clinical research and patient demand push psychiatrists …

Psych Congress Expands Psychedelics Focus as Policy Shifts Read More
Unisys Corporation
Regional

Unisys Researchers Push New Standard for AI Drug Models

September 9, 2026September 7, 2026 - by Timothy Alexander

BLUE BELL, PA — Unisys researchers are calling for drug-repurposing AI to be judged on whether its recommendations can withstand biological, safety, and evidentiary scrutiny — not predictive accuracy alone …

Unisys Researchers Push New Standard for AI Drug Models Read More

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