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

642 News Found

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


Gilead to acquire Arcellx in $7.8 billion bet on next-generation CAR T therapy
Biotech | February 26, 2026

Gilead to acquire Arcellx in $7.8 billion bet on next-generation CAR T therapy

Arcellx develops innovative immunotherapies for cancer and other incurable diseases


iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China
Clinical Trials | February 24, 2026

iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China

The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration


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