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Integra LifeSciences recalls all products manufactured at its Boston, MA facility due to inadequate endotoxin testing.[ Price : $8.95]
PhRMA and BIO praise FDA efforts to use digital health technology in drug and biologic regulatory decisions.[ Price : $8.95]
Federal Register notice: FDA announces a 6/28 advisory committee meeting to discuss an Ipsen Biopharmaceuticals NDA for palovarote...[ Price : $8.95]
Phathom Pharmaceuticals resubmits its NDA for vonoprazan tablets to treat erosive gastroesophageal reflux disease, responding to a...[ Price : $8.95]
FDA approves a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVies blockbuster Humira.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for the Collection o...[ Price : $8.95]
FDA publishes a draft guidance on using generally accepted scientific knowledge in drug and biological product applications.[ Price : $8.95]
FDA extends by three weeks its review of a Sarepta Therapeutics BLA for SRP-9001 (delandistrogene moxeparvovec), a gene therapy pr...