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WASHINGTON, D.C. — The Food and Drug Administration last week proposed a potential regulatory framework for medical devices powered by generative artificial intelligence, opening scrutiny of how manufacturers assess safety, …
FDA Weighs New Safety Rules for Generative AI Medical Devices Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration proposed requiring food manufacturers to disclose when they determine ingredients are generally recognized as safe, or GRAS, while federal health and …
FDA Moves to End Voluntary GRAS System for Food Ingredients Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration last week granted emergency authorization for Zoetis Inc.’s Simparica TRIO to treat New World screwworm infestations in dogs and puppies, expanding …
FDA Authorizes Simparica TRIO for Screwworm in Dogs Read More
WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) received Fast Track designation from the U.S. Food and Drug Administration for modzatinib as a potential treatment for moderate to severe lichen …
FDA Fast Track Status Advances Aclaris Lichen Planus Drug Read More
PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory …
Proscia Expands FDA-Cleared Digital Pathology Platform Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization for Elanco US Inc.’s CLiK Extra wound spray to prevent New World screwworm infestations in multiple …
FDA Authorizes Screwworm Prevention Drug for Livestock, Wildlife Read More
WASHINGTON, D.C. — The Centers for Medicare & Medicaid Services proposed a new pathway to shorten the lag between Food and Drug Administration authorization and national Medicare coverage for certain …
CMS Proposes RAPID Path to Cut Medicare Device Coverage Delays Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration granted accelerated approval to Replimune Inc.’s Tudriqev in combination with nivolumab for adults with unresectable advanced melanoma that progressed after PD-1-based …
FDA Clears Viral Therapy for Treatment-Resistant Melanoma Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) began its rolling U.S. application for QTORIN rapamycin during the second quarter as higher clinical, manufacturing and regulatory spending more than doubled …
Palvella Advances FDA Filing as Drug Spending Lifts Loss Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Takeda Pharmaceuticals America’s Orzeyful tablets for adults with narcolepsy type 1, making it the first treatment cleared to address the …
FDA Approves First Orexin-Targeting Narcolepsy Type 1 Drug Read More