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Results For "approval"

2608 News Found

Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1
Drug Approval | August 23, 2025

Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1

All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone


Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
News | August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension


European Commission grants approval of Ogsiveo
News | August 18, 2025

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors


Indoco Remedies receives final USFDA approval for rivaroxaban tablets
Drug Approval | August 13, 2025

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP
Drug Approval | August 11, 2025

Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP

Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle