FDA Approvals - FDA Reports More Deaths Linked To Contaminated Heparin (Medical News
FDA Reports More Deaths Linked To Contaminated Heparin (Medical News Today)
The US Food and Drug Administration released an update yesterday, 8th April, showing a dramatic rise in the number of deaths that may be due to patients having allergic reactions to contaminated heparin. The agency puts the new figure at 62 deaths in the last 15 months, which is considerably more than the 19 suggested last month.
FDA Approves ROTARIX(R) Rotavirus Vaccine (Medical News Today)
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that its partner, GlaxoSmithKline (GSK), has received approval from the U.S. Food and Drug Administration (FDA) for ROTARIX for the prevention of rotavirus gastroenteritis in infants. With only two doses, ROTARIX will offer protection against the most commonly circulating rotavirus types in the U.S.
BRAHMS Receives FDA Clearance To Market Automated Procalcitonin (PCT) Test (Medical News Today)
BRAHMS USA, Inc announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its patented Procalcitonin (PCT) Kryptor test. The automated test will be used in critically ill patients on the first day of ICU admission as an aid to assess their risk for progression to severe sepsis and septic shock.