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USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


Mandaviya and Puri hail MoU between IndianOil and Central TB Division for states of UP and Chhattisgarh
Policy | December 29, 2022

Mandaviya and Puri hail MoU between IndianOil and Central TB Division for states of UP and Chhattisgarh

This ambitious anti-TB campaign, as part of IOCL’s CSR, aims to ensure early identification of presumptive TB and prompt diagnosis using high-sensitivity diagnostic tests at the doorstep


Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
Drug Approval | December 29, 2022

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore


CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units
Policy | December 28, 2022

CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940


Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies
News | December 28, 2022

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze


Aurobindo's subsidiary Tergene Biotech receives SEC recommendation for pneumococcal 15 valent vaccine
Drug Approval | December 28, 2022

Aurobindo's subsidiary Tergene Biotech receives SEC recommendation for pneumococcal 15 valent vaccine

The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.


Alembic receives USFDA final approval for Fulvestrant Injection
Drug Approval | December 27, 2022

Alembic receives USFDA final approval for Fulvestrant Injection

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA


Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya
Policy | December 26, 2022

Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya

Centre and states need to work in tandem and in a collaborative spirit as was done during the previous surges for COVID-19 prevention and management