International Laboratories recalls one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislabeling.
FDA Review posts the latest Federal Register notices for the week ending 8/11/2017.
FDA and Chiasma reach agreement on a special protocol assessment on the design of a new Phase 3 clinical trial for its octreotide capsules product can...
FDA grants Gilead Sciences a priority review for its NDA for an investigational, fixed-dose combination of bictegravir (50mg) and emtricitabine/tenofo...
President Donald Trump says he is declaring the opioid epidemic a national emergency.
FDA clears a Renovis Surgical Technologies 510(k) to market posterior lumbar Tesera porous titanium interbody fusion systems.
FDA grants Anthera Pharmaceuticals an orphan drug designation for blisibimod for treating immunoglobulin A nephropathy.
TherapeuticsMD says it will submit additional endometrial safety information to address the only approvability issue raised in May-issued complete res...