FDA clears a Royal Philips 510(k) for the Philips BlueControl wearable light therapy device to treat mild psoriasis.
FDAs Oncologic Drugs Advisory Committee unanimously votes to support approval of a Novartis BLA for CTL019 (tisagenlecleucel-T), a chimeric antigen re...
A Tufts Center for the Study of Drug Development panel of experts says that a lack of consistent FDA regulatory policy can hinder development of abuse...
FDA accepts for review a Pfizer supplemental NDA for Xeljanz (tofacitinib citrate) for treating adult patients with moderately to severely active ulce...
The Trump Administration renews its call for Congress to double user fees paid by industry to help with the governments budget.
FDA clears a TechLab 510(k) for the Tri-Combo Parasite Screen test for detecting Giardia, Cryptosporidium, and Entamoeba histolytica, the three most c...
FDA grants Allena Pharmaceuticals an orphan drug designation for ALLN-177, an oral formulation of oxalate decarboxylase for treating primary hyperoxal...
FDA releases an FDA-483 with nine inspection observations from its inspection at Magellan Diagnostics, the subject of an agency warning about potentia...