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FDA gives Aurobindo Pharma a four-observation Form FDA-483 after inspecting the firms Unit XIV active pharmaceutical ingredient (n...[ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on ANDA bioequivalence ...[ Price : $8.95]
New FDA research on direct-to-consumer television ads finds that disclosures could help viewers in differentiating between progres...[ Price : $8.95]
Abiomed recalls its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patients circul...[ Price : $8.95]
The Justice Department resolves civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the feder...[ Price : $8.95]
FDA grants Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with re...[ Price : $8.95]
FDA approves a Krystal Biotech BLA for Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy for treating wounds in pat...[ Price : $8.95]
FDA clears a Beta Bionics 510(k) for its Bionic Pancreas for treating Type 1 diabetes in patients aged six years and older.