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Results For "Food-and-Drug-Administration"

1346 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


Caplin Steriles gets USFDA approval for Sodium Phosphate injection
Drug Approval | February 25, 2026

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake


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


Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
Clinical Trials | February 23, 2026

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar

BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data


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


Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg
Drug Approval | February 19, 2026

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension


USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
Drug Approval | February 17, 2026

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.