Food and Drug Administration (FDA)
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Reaffirms Biocon’s Capability to Manufacture Biosimilars for Patients in U.S.
First hospital in US to acquire French medtech firm’s CT-Navigation™ system to increase accuracy in radiology procedures, while decreasing treatment times and radiation exposure of patients and healthcare professionals
Ziextenzo (pegfilgrastim) is a long-acting version of filgrastim and is indicated to decrease the incidence of infection in cancer patients.
In clinical trials, Talicia demonstrated 90% efficacy in the eradication of H. pylori in studies and is the only rifabutin-based therapy on the market.
Endorsement of pivotal development program in recurrent glioblastoma (rGBM) from both EMA and FDA
Late Friday, President Donald Trump put forth Hahn’s name to take over the top spot of the nation’s regulatory agency.
There are four PDUFA dates the U.S. Food and Drug Administration has scheduled for the rest of November to decide on drug approvals. Here’s a look.
ObsEva SA announced that the U.S. Food and Drug Administration has allowed the Company to begin enrolling patients in IMPLANT 3, the U.S pivotal Phase 3 clinical trial of nolasiban in women undergoing embryo transfer following in-vitro fertilization.
The approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.
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