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

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia

Industry needs to establish a self-regulatory body to maintain the quality of the pharma products, says Dr Mandaviya

BASF and Merck KGaA introduce a new standard for electronic exchange of quality and regulatory data

The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information

Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.

USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure

Theramex select CARA Life Sciences Platform to consolidate and digitise Regulatory Processes

Theramex were searching for a platform to digitise the manual processes across their R&D landscape

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant

The company increases its efficiency and is able to face the growing demand for its services.

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India

Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer