Medical Device | December 23, 2021
U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath
Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters
Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
The capsules are the generic version of the reference listed drug Mycobutin
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains
FDA changes inspection classification of the facility to Voluntary Action Indicated
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
The tablets are indicated for the treatment of pulmonary arterial hypertension
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