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FDA approves an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as mani...[ Price : $8.95]
Entrada Therapeutics says an ongoing clinical hold against the companys Phase 1 trial of ENTR-601-44 in Duchenne muscular dystroph...[ Price : $8.95]
Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to...[ Price : $8.95]
FDA publishes an immediately-in-effect guidance on developing drugs and biologics to prevent or treat some Covid-19.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.[ Price : $8.95]
FDA declines to ban music in all DTC ads during the presentation of risk information.[ Price : $8.95]
FDA clears a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation and pulse rate for ove...[ Price : $8.95]
In a likely attempt to rebut a critical BMJ investigation, FDA and CDC officials explain, defend, and praise the Vaccine Adverse E...