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WASHINGTON, D.C. — The Food and Drug Administration is seeking revisions to prescribing information for testosterone replacement therapies after concluding that newer clinical evidence no longer supports certain longstanding restrictions …
FDA Seeks Testosterone Label Changes After Evidence Review Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil), expanding access to a single-dose influenza treatment and prevention option ahead …
FDA Clears First Generic Xofluza Ahead of Flu Season Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has expanded the approved use of Tzield (teplizumab) to children ages 8 to 17 who have been recently diagnosed with Stage …
FDA Expands Tzield Use for Children With Type 1 Diabetes Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Rextovy, an over-the-counter naloxone nasal spray for emergency treatment of opioid overdoses, expanding consumer access to a medication widely …
FDA Approves OTC Naloxone Spray, Expanding Overdose Access Read More
WILMINGTON, DE — AstraZeneca’s TRUQAP (capivasertib) has won U.S. approval for a subset of patients with advanced prostate cancer, providing the first biomarker-targeted treatment option for an aggressive form of …
FDA Clears AstraZeneca Prostate Cancer Therapy for PTEN Patients 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 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