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1152 News Found

Biocon Biologics receives Health Canada approval for Yesafili
Drug Approval | June 27, 2025

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


FDA approves Merck’s enflonsia for prevention of RSV in infants
Drug Approval | June 12, 2025

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months


Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Drug Approval | June 09, 2025

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)


Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy
News | June 06, 2025

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy

Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)


Biocon gets approval for diabetes drug Liraglutide in India
Clinical Trials | June 03, 2025

Biocon gets approval for diabetes drug Liraglutide in India

The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus


Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP
Drug Approval | May 24, 2025

Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP

Allopurinol is used to prevent or lower high uric acid levels in the blood


Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin


Zydus receives final approval from USFDA for Isotretinoin Capsules USP
Drug Approval | May 24, 2025

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne