7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met

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