Zydus receives final approval from the USFDA for Pitavastatin Tablets

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

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.

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

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial

Aji Bio-Pharma develops highly functional ancestral RNA ligase

This artificial RNA ligase has higher thermostability than natural RNA ligase

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