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Results For "U.S.-Food-and-Drug-Administration"

610 News Found

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir
News | December 24, 2021

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir

The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


Pfizer’s Covid-19 pill gets U.S. FDA clearance
Drug Approval | December 23, 2021

Pfizer’s Covid-19 pill gets U.S. FDA clearance

Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid


Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn
Biotech | December 22, 2021

Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn

Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant


Pfizer’s Covid-19 drug 90 % effective
News | December 15, 2021

Pfizer’s Covid-19 drug 90 % effective

The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation


Dr Reddy’s launch Venlafaxine ER tablets in the US
Drug Approval | December 10, 2021

Dr Reddy’s launch Venlafaxine ER tablets in the US

The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.