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PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) has asked the U.S. Food and Drug Administration to grant Rare Pediatric Disease Designation for its experimental SkinJect therapy in patients with …
ICYMI: Medicus Seeks FDA Rare Disease Status for Skin Cancer Therapy Read More PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) has asked the U.S. Food and Drug Administration to grant Rare Pediatric Disease Designation for SkinJect, its experimental treatment for patients with …
Medicus Seeks FDA Rare Disease Status for Skin Cancer Therapy Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has cleared the first over-the-counter continuous glucose monitor for children, expanding access to glucose-tracking technology as rates of prediabetes and Type …
FDA Expands OTC Glucose Monitor Access to Children Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the first generic animal drug for treating New World screwworm infestations in dogs and cats, expanding the federal government’s …
FDA Authorizes First Generic Treatment for New World Screwworm in Pets Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized bemotrizinol for use in over-the-counter sunscreens, clearing the first new sunscreen active ingredient for the U.S. market in more …
FDA Adds First New Sunscreen Ingredient in Decades Read More
WILMINGTON, DE — AstraZeneca has secured U.S. regulatory approval for IMFINZI (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) therapy for adults with previously untreated high-risk non-muscle-invasive bladder cancer, expanding the …
AstraZeneca Wins FDA Approval for IMFINZI in Early Bladder Cancer Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has released draft guidance that could shorten development timelines for gene therapies by allowing drugmakers to make greater use of existing …
FDA Issues Gene Therapy Guidance Aimed at Faster Reviews Read More
HORSHAM, PA — The U.S. Food and Drug Administration has approved a label expansion for Johnson & Johnson’s (NYSE: JNJ) TREMFYA, allowing the company to market clinical evidence showing the …
FDA Expands TREMFYA Label to Include Joint Damage Data in Psoriatic Arthritis Read More
PHILADELPHIA, PA — Medicus Pharma (Nasdaq: MDCX) has advanced its SkinJect® treatment into registrational development for Gorlin Syndrome, a rare genetic disorder that causes recurring skin cancers and often requires …
Medicus Pharma Seeks FDA Path for Rare Skin Cancer Disorder Read More WILMINGTON, DE — AstraZeneca and Daiichi Sankyo have secured U.S. approval for DATROWAY as a first-line treatment for certain patients with metastatic triple-negative breast cancer, expanding treatment options in a …
AstraZeneca, Daiichi Sankyo Win FDA Approval for DATROWAY in Breast Cancer Read More