Strides flagship facility in Bangalore receives USFDA inspection closure

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

Briefs: Alkem and Krsnaa Diagnostics

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

National Health Authority facilitating Quick OPD registration in 365 hospitals

More than 5 lakh patients availed the benefit of queue-less OPD registration using this service

Venus Remedies gets marketing approval for cancer drugs from Uzbekistan, Palestine

The marketing authorisations for three generic drugs signifying advances in cancer treatment will considerably benefit thousands of patients by improving access, ensuring affordability

Research underscores Beyfortus’ potential to prevent RSV disease in infants

The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile

Aji Bio-Pharma develops highly functional ancestral RNA ligase

This artificial RNA ligase has higher thermostability than natural RNA ligase

Genomics, big data among key themes driving M&A activity in medical devices, says GlobalData

A total of 889 M&A deals were announced in the medical devices sector in 2022 worth $93 billion

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency