Zydus receives final approval from the USFDA for Pitavastatin Tablets

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

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

Sanofi India posts Q4 CY22 PAT at Rs. 130.9 Cr

The company has reported total income of Rs. 691.9 crores during the quarter ended December 31, 2022

Govt. appoints Rajeev Raghuvanshi new DGCI

MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates

Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months

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