Alembic gets USFDA final approval for ANDA Docetaxel Injection

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region

Sanofi reaffirms commitment to rare diseases in India

Receives Subject Expert Committee recommendation to bring new therapies of Pompe, ASMD to India

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China

Agilent announces cell analysis workflow automation for immuno-oncology, virology, and vaccine development markets

New workflow integrates the xCELLigence RTCA HT with the BioTek BioSpa 8 Automated Incubator

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Strides flagship facility in Bangalore receives USFDA inspection closure

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