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Results For "FDA"

1712 News Found

Medtronic announces first patient implants for bladder incontinence
Medical Device | March 25, 2022

Medtronic announces first patient implants for bladder incontinence

Titan 2 pivotal study to evaluate implantable tibial neuromodulation (TNM) device to help expand patient access to advanced therapy


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial


Glenmark receives ANDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately


Biological Dynamics study demonstrates detection of early-stage cancers
Biotech | March 21, 2022

Biological Dynamics study demonstrates detection of early-stage cancers

In a Nature Communications Medicine publication, the Verita proprietary platform detected 96 per cent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis


physIQ and CellCarta collaborate to personalise vaccine development
Biotech | March 21, 2022

physIQ and CellCarta collaborate to personalise vaccine development

Moving well beyond the traditional approach of testing a vaccine’s collective response in large populations, this precision approach can identify how an individual’s own immune system responds to a vaccine, offering an unprecedented opportunity to measure vaccine safety and effectiveness


Zydus receives PAS approval for Mycophenolate Mofetil
Drug Approval | March 21, 2022

Zydus receives PAS approval for Mycophenolate Mofetil

The drug is indicated for use in combination with other drugs


Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer
Drug Approval | March 17, 2022

Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer


Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA
Biotech | March 16, 2022

Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA

The USFDA has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical needs and facilitates a faster approval process


Unichem receives ANDA approval for hypertension drug
Drug Approval | March 16, 2022

Unichem receives ANDA approval for hypertension drug

Nebivolol is used alone or together with other medicines to treat high blood pressure


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