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

134 News Found

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


Biocon settles suit with Celgene for generic Revlimid
Biotech | September 08, 2021

Biocon settles suit with Celgene for generic Revlimid

Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020


Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1
News | September 01, 2021

Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1

The company aims to continue its expansion via organic and inorganic routes to increase production capacity and product portfolio


US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723
Drug Approval | August 31, 2021

US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723

The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit