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3155 News Found

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


Samples taken from Marion Biotech Noida facility sent to RDTL, Chandigarh for testing
News | December 30, 2022

Samples taken from Marion Biotech Noida facility sent to RDTL, Chandigarh for testing

There have been reports from Uzbekistan concerning contaminated cough syrup Dok1 Max made by Indian company Marion Biotech, Noida, Uttar Pradesh


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


World's first intranasal vaccine iNCOVACC will be rolled out in the fourth week of January
News | December 29, 2022

World's first intranasal vaccine iNCOVACC will be rolled out in the fourth week of January

The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunization during public health emergencies and pandemics


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


NAFLD clinical trial activity catching up in China but lacks substantial domestic participation, says GlobalData
News | December 27, 2022

NAFLD clinical trial activity catching up in China but lacks substantial domestic participation, says GlobalData

China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade.