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Results For "FDA"

1787 News Found

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


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting
interviews | March 13, 2022

Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting

Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements


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


New data show Lynparza demonstrated overall survival benefit in early breast cancer
Biotech | March 12, 2022

New data show Lynparza demonstrated overall survival benefit in early breast cancer

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial


Cancer surgeons gather in Delhi to learn new cancer therapies
Public Health | March 11, 2022

Cancer surgeons gather in Delhi to learn new cancer therapies

Experts will speak about primary tumours of the nervous system and also the tumours of other body parts which get metastasized to the nervous system