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Results For "authorization"

302 News Found

European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis
Drug Approval | February 20, 2024

European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis

VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU


Glenmark partners Pfizer to launch Abrocitinib in India
Drug Approval | February 01, 2024

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India


Orchid Pharma's Exblifeb granted EMA approval
Drug Approval | February 01, 2024

Orchid Pharma's Exblifeb granted EMA approval

Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia


Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg
Drug Approval | January 20, 2024

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe


AbbVie launches Produodopa for treatment of parkinson's disease in EU
News | January 20, 2024

AbbVie launches Produodopa for treatment of parkinson's disease in EU

Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations


Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India
News | January 17, 2024

Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India

Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa


Briefs: Venus Remedies and Shivalik Rasayan
News | January 13, 2024

Briefs: Venus Remedies and Shivalik Rasayan

Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA


FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto
Drug Approval | December 12, 2023

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto

The CVMP recommends the product for approval for the treatment and persistent killing of fleas


European Commission approves Pfizer’s Elrexfio for multiple myeloma
Drug Approval | December 09, 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial