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AbbVie sBLA for Skyrizi in Crohns

[ Price : $8.95]

AbbVie submits a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (induction dose) and 180 mg and 360 mg subcutane...

Novocure Phase 3 Study Misses Primary Endpoint

[ Price : $8.95]

Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields together with paclitaxel in patie...

Final Guide on Product Tracing Enforcement

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security Requirements Under Sect...

Enforcement Deferred on Drug Security Needs

[ Price : $8.95]

FDA posts a guidance on new enforcement deferments affecting enhanced drug distribution security requirements.

Inmar Recalls Products Due to Rodent Infestation

[ Price : $8.95]

Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, di...

Comments Sought on Pepaxtos Proposed Withdrawal

[ Price : $8.95]

CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan fluf...

CDRH Qualifies Tool on Material Biostability

[ Price : $8.95]

CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated...

Fresenius Home Hemodialysis Guide Cleared

[ Price : $8.95]

FDA clears a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the companys VersiHD chr...

Redx Orphan Status for Pulmonary Fibrosis

[ Price : $8.95]

FDA grants Redx an orphan drug designation for zelasudil (RXC007) for treating idiopathic pulmonary fibrosis.

FDA Updates HeartWare Device Alert

[ Price : $8.95]

Medtronic issues an Urgent Medical Device Communication about its HeartWare Ventricular Assist Device (HVAD) systems and a newly i...