Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 22

Results For "US-FDA"

262 News Found

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


BioVaxys expands cancer vaccine platform
Biotech | March 31, 2022

BioVaxys expands cancer vaccine platform

BVX-0922 to target colorectal cancer under investigator-sponsored IND


Jeffrey W. Fisher is the recipient of the Arnold J Lehman SOT award
News | March 16, 2022

Jeffrey W. Fisher is the recipient of the Arnold J Lehman SOT award

Career achievement for contributions in Physiologically based pharmacokinetic (PBPK) and biologically based does response (BBDR) modelling tools


Granules Pharmaceuticals clears USFDA audit
News | March 15, 2022

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region


Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting
interviews | March 13, 2022

Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting

Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements


WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine
News | February 24, 2022

Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine

100% efficacy against severe Covid-19 disease and hospitalizations


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation


Granules receives ANDA approval for anti-depressant medication
Drug Approval | February 03, 2022

Granules receives ANDA approval for anti-depressant medication

It has a total of 50 ANDA approvals from USFDA