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Food and Drug Administration

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
Food and Drug Administration
Cancer / National

FDA Approves Rasonque as Pancreatic Cancer Treatment

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

WASHINGTON, D.C. — The Food and Drug Administration approved Revolution Medicines Inc.’s Rasonque for certain adults with metastatic pancreatic adenocarcinoma after a clinical trial showed the drug nearly doubled median …

FDA Approves Rasonque as Pancreatic Cancer Treatment Read More

Food and Drug Administration
National

FDA Clears Abbott Device to Continuously Track Ketones, Glucose

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

WASHINGTON, D.C. — U.S. regulators authorized Abbott Diabetes Care’s Libre Duo 10 Day for people with diabetes aged 2 and older, introducing the first U.S. wearable capable of continuously monitoring …

FDA Clears Abbott Device to Continuously Track Ketones, Glucose Read More
A white and blue DNA double helix structure against a dark background
Health / Medical / National

FDA Clears First Gene Therapy for Rare Glycogen Disorder

August 24, 2026August 22, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration last week granted accelerated approval to Ultragenyx Pharmaceutical Inc.’s Genglycos, the first treatment for glycogen storage disease type Ia, after a clinical …

FDA Clears First Gene Therapy for Rare Glycogen Disorder Read More
U.S. Food and Drug Administration (FDA)
Health / Medical / National

FDA Clears Robotic Blood Draws to Ease Staffing Shortages

August 24, 2026August 22, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration last week authorized the first standalone robotic device capable of drawing blood without hands-on operator intervention, allowing a single trained phlebotomist to …

FDA Clears Robotic Blood Draws to Ease Staffing Shortages Read More

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