FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults

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

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

Lupin, Cost Plus Drug and COPD Foundation to expand access to medication for COPD patients

This collaboration marks a significant milestone in countering the disease burden by enhancing access to products for patients in the US

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy

USFDA accepts biologics license application for GC Biopharma's GC5107B

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Univar Solutions expands specialty pharmaceutical and nutraceutical ingredient portfolios with Grace Syloid FP Silica

Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network

Cosette Pharmaceuticals acquires Intrarosa from Endoceutics

Acquisition accelerates Cosette’s women’s health portfolio; with a differentiated, commercial stage, patent protected product