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Neo Tect Kit Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that CIS Bio Internationals Neo Tect Kit was not withdrawn from sale for safety or effecti...

Regulatory Review Period for Mercks Ilumya

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Mercks psoriasis drug Ilumy...

Guide on Bone Anchor 510(k) Submissions

[ Price : $8.95]

FDA releases a final guidance on Bone Anchors Premarket Notification (510(k)Submissions.

OPDP Hits Outlook Pharma on Google Search Link

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion (OPDP) sends Outlook Pharmaceuticals a Warning Letter over a sponsored link on Googles...

Biohaven Pharma Migraine Drug Approved

[ Price : $8.95]

FDA approves a Biohaven Pharmaceutical NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults.

Sanofi Pays $12 Million to Settle False Claims

[ Price : $8.95]

Sanofi-Aventis agrees to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks t...

Pfizer, Lilly BLA for Osteoarthritis Pain

[ Price : $8.95]

FDA accepts for review a Pfizer and Eli Lilly BLA for tanezumab 2.5 mg administered subcutaneously for patients with chronic pain ...

BLA for Multiple Myeloma Therapy Approved

[ Price : $8.95]

FDA approves a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone for treating adults wi...

FDA Clears FX Shoulder Expanded Glenoid Baseplate

[ Price : $8.95]

FDA clears an FX Shoulder 510(k) for its Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse ...

Sandoz $195 Million Fine in Price Fixing Scheme

[ Price : $8.95]

Sandoz agrees to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixin...