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Food and Drug Administration

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

Palvella Therapeutics
Health / Medical

ICYMI: Palvella Seeks FDA Approval for Rare-Disease Skin Therapy

September 4, 2026September 3, 2026 - by Timothy Alexander

WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) recently completed its U.S. application for approval of QTORIN™ rapamycin to treat microcystic lymphatic malformations, putting the Wayne-based biotechnology company on a …

ICYMI: Palvella Seeks FDA Approval for Rare-Disease Skin Therapy Read More
Johnson & Johnson
Regional

FDA Clears J&J’s IMAAVY as First Drug for Rare Blood Disease

September 2, 2026August 31, 2026 - by Timothy Alexander

SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) secured U.S. Food and Drug Administration approval for IMAAVY to treat warm autoimmune hemolytic anemia in patients 12 and older who …

FDA Clears J&J’s IMAAVY as First Drug for Rare Blood Disease Read More

U.S. Food and Drug Administration (FDA)
Health / Medical / National

FDA Approves Mimrylo to Cut Phlebotomy Need in Blood Disorder

September 1, 2026August 30, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration approved Takeda Pharmaceuticals America Inc.’s Mimrylo for adults with polycythemia vera whose disease is not adequately controlled with existing therapy, introducing a …

FDA Approves Mimrylo to Cut Phlebotomy Need in Blood Disorder Read More
U.S. Food and Drug Administration
National

FDA Approves Lisraya as Oral Treatment for Dermatomyositis

September 1, 2026August 30, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration approved Priovant Therapeutics Inc.’s Lisraya for adults with dermatomyositis, providing an oral treatment for the rare autoimmune disease after a Phase 3 …

FDA Approves Lisraya as Oral Treatment for Dermatomyositis Read More
Food and Drug Administration
National

FDA Authorizes Generic Ivermectin to Protect Cattle From Screwworm

August 31, 2026August 30, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration authorized emergency use of Bimectin ivermectin injections to prevent New World screwworm infestations in certain cattle, expanding the number of available drugs …

FDA Authorizes Generic Ivermectin to Protect Cattle From Screwworm Read More

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