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Results For "approval"

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CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


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