Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 6

Results For "European-Medicines-Agency"

181 News Found

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


Asahi Kasei offers pharmaceutical excipient Ceolus with nitrite concentration of 0.1 ppm or less
News | February 29, 2024

Asahi Kasei offers pharmaceutical excipient Ceolus with nitrite concentration of 0.1 ppm or less

Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


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


EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
Drug Approval | January 23, 2024

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023


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