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Results For "U.S.-Food-and-Drug-Administration"

609 News Found

FDA accepts Teva’s NDA for long-acting schizophrenia injection
Drug Approval | February 21, 2026

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations


FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients
Drug Approval | February 21, 2026

FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy


Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria
Clinical Trials | February 20, 2026

Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria

The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent


FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue
Drug Approval | February 14, 2026

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”


Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke
Clinical Trials | February 07, 2026

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke


Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk
News | January 17, 2026

Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk

The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk


Sun Pharma launches Unloxcyt for advanced cutaneous squamous cell carcinoma treatment
News | January 16, 2026

Sun Pharma launches Unloxcyt for advanced cutaneous squamous cell carcinoma treatment

UNLOXCYT is an evolution in checkpoint inhibition and is now available for the treatment of adults in the U.S. with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation


EMA and FDA unveil joint AI principles to transform drug revelopment
R&D | January 16, 2026

EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation


Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US
News | January 14, 2026

Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is an antihistamine eye drop, indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander