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Food and Drug Administration

Medicus Pharma
Regional

FDA Clears Medicus to Start Gorlin Syndrome Drug Study

July 29, 2026July 28, 2026 - by Timothy Alexander

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

Food and Drug Administration
Health / Medical / National

FDA Selects Dexcom for Medicare Digital Health Pilot

July 28, 2026July 26, 2026 - by Maryann Pugh

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
Food and Drug Administration
National

FDA Moves to Eliminate Two Food Dye Authorizations

July 27, 2026July 26, 2026 - by Maryann Pugh

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food dye authorization and proposing to eliminate another, advancing the Trump administration’s effort to remove outdated color …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

MAXONA Pharmaceuticals
Research

FDA Clears MAXONA Pain Drug for Phase 2 Trial

July 22, 2026July 22, 2026 - by Timothy Alexander

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
U.S. Food and Drug Administration (FDA)
Regional / Technology

LifeLens Wins Expanded FDA Clearance for Patient Monitoring Platform

July 22, 2026 - by Timothy Alexander

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

Food and Drug Administration
Health / Medical / National

FDA Approves First Oral PCSK9 Drug for High Cholesterol

July 20, 2026 - by Maryann Pugh

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
Medicus Pharma
Regional

ICYMI: Medicus Advances Leaner Teverelix Trial After FDA Review

July 20, 2026 - by Timothy Alexander

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

orange juice in clear drinking glass
National

FDA Eases Orange Juice Rule, Reducing Import Pressure

July 20, 2026July 19, 2026 - by Maryann Pugh

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
FDA
National

FDA Authorizes Horse Ivermectin Against Screwworm Threat

July 19, 2026 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration authorized prescription ivermectin for the short-term prevention of New World screwworm infestations in horses, expanding federal preparations against a parasite capable of …

FDA Authorizes Horse Ivermectin Against Screwworm Threat Read More
Medicus Pharma
Regional

Medicus Cuts Planned Teverelix Trial Enrollment by Two-Thirds

July 18, 2026July 17, 2026 - by Timothy Alexander

PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) plans to test its Teverelix drug candidate in about 126 patients after receiving FDA feedback and central ethics approval for a redesigned …

Medicus Cuts Planned Teverelix Trial Enrollment by Two-Thirds Read More

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