Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 7

Results For "marketing-authorization"

160 News Found

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


Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’
News | November 14, 2023

Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada


ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'
News | October 16, 2023

ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'

NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy