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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications Fr...[ Price : $8.95]
FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the orga...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for N...[ Price : $8.95]
Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.[ Price : $8.95]
FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessi...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...[ Price : $8.95]
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...