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Results For "Food-and-Drug-Administration"

1021 News Found

USFDA EUA for point-of-care Covid-19 rapid PCR test
Medical Device | March 17, 2022

USFDA EUA for point-of-care Covid-19 rapid PCR test

DASH enables non-laboratory personnel to insert a nasal swab specimen directly into our test cartridge and then load the cartridge into the DASH instrument, providing an accurate result in about 15 minutes


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


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


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


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


UFDA approves first generic of Symbicort to treat asthma and COPD
Drug Approval | March 16, 2022

UFDA approves first generic of Symbicort to treat asthma and COPD

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)


USFDA grants Orphan Drug Designation for Akantior
Biotech | March 15, 2022

USFDA grants Orphan Drug Designation for Akantior

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets


Granules Pharmaceuticals clears USFDA audit
News | March 15, 2022

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility


Adlarity receives USFDA approval for treatment of Alzheimer
Drug Approval | March 14, 2022

Adlarity receives USFDA approval for treatment of Alzheimer

First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for the treatment of Alzheimer's-related dementia


S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.
Medical Device | March 13, 2022

S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.

It signals Cordis' renewed investment in innovation