Research & Development
LFB Receives FDA Approval of Sevenfact, a New Recombinant Coagulation Factor VIIa, for the Treatment of Adults and Adolescents with Hemophilia A or B with Inhibitors
8 April 2020 - - The US Food and Drug Administration has approved the Biologics License Application 2061 for Sevenfact, a new recombinant coagulation Factor VIIa [coagulation factor VIIa (recombinant)...
Agenus awarded FDA's fast track designation for balstilimab for treating cervical cancer
8 April 2020 - Immuno-oncology company Agenus Inc (NASDAQ:AGEN) reported on Tuesday the receipt of US Food and Drug Administration (FDA) Fast Track designation for investigation of balstilimab (anti-P...
Rapid Medical concludes enrollment for the TIGER clinical study in ischemic stroke patients
8 April 2020 - Neurovascular devices company Rapid Medical reported on Tuesday the completion of enrollment under the TIGER (Treatment with Intent to Generate Reperfusion) study of TIGERTRIEVER for th...
Nitiloop awarded FDA clearance for treating chronic total occlusion prior to stent intervention
8 April 2020 - Israeli vascular company Nitiloop Ltd reported on Tuesday the receipt of US Food & Drug Administration 510(k) clearance for its NovaCross CTO Microcatheter for treating chronic tota...
Polaryx Therapeutics wins FDA approval for PLX-200 IND to treat patients with juvenile neuronal ceroid lipofuscinosis
8 April 2020 - Biotech company Polaryx Therapeutics reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for Investigational New Drug Application (IND) of PLX-200...
Cumberland Pharmaceuticals starts initiative to increase Vaprisol injection availability
8 April 2020 - Cumberland Pharmaceuticals Inc (NASDAQ: CPIX) a specialty pharmaceutical company, has started an initiative to increase availability of Vaprisol (conivaptan hydrochloride) injection int...