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

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.

Briefs: Alkem and Krsnaa Diagnostics

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

No link between the use of ranitidine and cancer risk, claims Nature

N-nitroso dimethylamine (NDMA) is a probable human carcinogen and tts effects on humans rely on observational studies.

SERDA therapeutics submits IND for wound debridement agent

Clinical studies are expected to start in Q2 2023.

Novartis appoints Gilbert Ghostine Chairman-Designate of Sandoz Board of Directors

Ghostine has served as CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste company, since 2014.

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