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WASHINGTON, D.C. — The Food and Drug Administration licensed the first freeze-dried plasma product for U.S. use last week, creating a room-temperature option for treating adult patients when conventional plasma …
FDA Clears First Freeze-Dried Plasma for Emergency Use Read More
WILMINGTON, DE — Inhibikase Therapeutics Inc. (Nasdaq: IKT) has received U.S. Food and Drug Administration Orphan Drug Designation for its lead pulmonary arterial hypertension drug candidate, a regulatory milestone that …
Inhibikase Wins FDA Orphan Status for PAH Drug Candidate Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) received U.S. Food and Drug Administration authorization to begin a registrational Phase 2b study of its SkinJect treatment in patients with Gorlin …
FDA Clears Medicus to Start Gorlin Syndrome Drug Study Read More WASHINGTON, D.C. — The Food and Drug Administration selected Dexcom Inc. as the first participant in a federal pilot linking digital health-device oversight with a Medicare payment model that rewards …
FDA Selects Dexcom for Medicare Digital Health Pilot Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is revoking one petroleum-based food dye authorization and proposing to eliminate another, advancing the Trump administration’s effort to remove outdated color …
FDA Moves to Eliminate Two Food Dye Authorizations Read More
MALVERN, PA — MAXONA Pharmaceuticals has received U.S. Food and Drug Administration clearance to begin a Phase 2 clinical trial of its investigational non-opioid pain therapy, advancing the company’s effort …
FDA Clears MAXONA Pain Drug for Phase 2 Trial Read More
IVYLAND, PA — LifeLens Technologies has received expanded U.S. Food and Drug Administration 510(k) clearance for its wearable physiological monitoring platform, broadening the range of clinical measurements the device can …
LifeLens Wins Expanded FDA Clearance for Patient Monitoring Platform Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Merck’s Lipfendra as the first oral PCSK9 inhibitor for adults with high cholesterol, introducing a once-daily alternative to injectable drugs …
FDA Approves First Oral PCSK9 Drug for High Cholesterol Read More PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) is moving toward activation of a redesigned Phase 2 Teverelix trial after receiving FDA feedback and central ethics approval, cutting planned enrollment …
ICYMI: Medicus Advances Leaner Teverelix Trial After FDA Review Read More
WASHINGTON, D.C. — The Food and Drug Administration on Friday lowered the minimum sugar-content standard for pasteurized orange juice, a regulatory change intended to let processors use more domestic citrus …
FDA Eases Orange Juice Rule, Reducing Import Pressure Read More