Venus Remedies secures regulatory approvals for three key oncology drugs in Ukraine

Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results

Pfizer receives regulatory approvals to complete the acquisition of Seagen

Announces changes in the commercial organization to incorporate Seagen and improve focus, speed and execution

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