FDA approves a Promius Pharma NDA for Tosymra (sumatriptan nasal spray) 10 mg, indicated for the acute treatment of migraine with or without aura in a...
FDA announces a 3/25-26 General and Plastic Surgery Devices Panel meeting to discuss topics concerning the benefit-risk profile of breast implants.
FDA extends by 30 days the comment period for a 12/2018 public workshop and a related white paper, Evaluating Whether Activities Are Servicing or Rema...
FDA denies an 8/2018 Pfizer petition urging it to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copi...
FDA clears a Masimo 510(k) for the measurement of respiration rate from the pleth on the MightySat Rx spot-check fingertip pulse oximeter, as well as ...
FDA approves an expanded use for AbbVies Imbruvica (ibrutinib) combination use with Gazyva (obinutuzumab) for adult patients with previously untreate...
CDRH says it approved a record 106 novel devices, eclipsing the 40-year record it set in 2017 when 99 such devices were approved.
A welcome back email from CDER director Janet Woodcock tells employees returning to work from the just-ended partial government shutdown to pick up th...