Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 12

Results For "US-Food-and-Drug-Administration"

129 News Found

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Boehringer Ingelheim gets CDSCO nod for Jardiance
Drug Approval | November 23, 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment
Biotech | November 18, 2021

US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment

The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease


Sluggish exports to cap pharma revenue growth at 9% this fiscal
News | November 17, 2021

Sluggish exports to cap pharma revenue growth at 9% this fiscal

A CRISIL study of 207 pharmaceutical companies that account for 55% of the Rs 3.2 lakh crore-a-year sector revenue indicates as much.


Solve.Care and AliveCor partner to connect KardiaMobile users with physicians
Digitisation | October 29, 2021

Solve.Care and AliveCor partner to connect KardiaMobile users with physicians

The collaboration provides KardiaMobile users quick access to doctors worldwide for consultations about their ECG readings


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction