Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 15

Results For "FDA"

2507 News Found

FDA greenlights Biocon’s Liraglutide for chronic weight management
News | February 25, 2026

FDA greenlights Biocon’s Liraglutide for chronic weight management

Liraglutide is a drug-device combination formulation used in the treatment of chronic weight management


FDA approves Lilly's Zepbound multi-dose KwikPen for obesity treatment
Drug Approval | February 24, 2026

FDA approves Lilly's Zepbound multi-dose KwikPen for obesity treatment

In 2025, over 1 million patients accessed Lilly treatments through LillyDirect


Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy
Drug Approval | February 24, 2026

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause


FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL
Drug Approval | February 23, 2026

FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL

The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years


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


FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
Drug Approval | February 21, 2026

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study


Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer
Drug Approval | February 20, 2026

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care


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