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

98 News Found

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


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants
Drug Approval | August 12, 2021

SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants

SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial


GSK files application for MMR vaccine in the US
News | August 11, 2021

GSK files application for MMR vaccine in the US

If approved it will bring a second source of MMR vaccine to the US market


NATCO receives approval for Ibrutinib tablets from ANDA
News | April 11, 2021

NATCO receives approval for Ibrutinib tablets from ANDA

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths