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Regulatory Review Period for Ciplas Zemdri

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Cipla USAs Zemdri (pla...

Viking Reports Positive Data on NASH Drug

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Viking Therapeutics provides encouraging top-line data from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirme...

Judge Hits Precision Lens with $487 Million Fine

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A Minnesota federal judge enters a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for v...

Abbott Spinal Stimulation Devices OK for Back Pain

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FDA approves an expanded indication for Abbott spinal cord stimulation (SCS) devices treating chronic back pain in those who have...

Comments on Electronic Systems Q&A Draft

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Five stakeholders comment on an FDA question-and-answer draft guidance on using electronic systems, records, and signatures in cli...

Split Vote on Sarepta Gene Therapy

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FDAs Cellular, Tissue, and Gene Therapies Advisory Committee gives a split vote of 8 to 6 to recommend approval of a Sarepta BLA s...

Regulatory Review Period for Cablivi

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Cablivi (caplacizum...

Allergan Skin Smoother Approved by FDA

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FDA approves Allergan Aesthetics Skinvive by Juvderm and its use to improve skin smoothness of the cheeks in adults.

Pedicle Screw Bone Awl Cleared

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FDA clears a Waypoint Orthopedics 510(k) for the Waypoint GPS, a smart bone awl for use during pedicle screw pilot hole drilling.

Guide on Reporting Animal Drug Shortages

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FDA releases a final guidance entitled Reporting and Mitigating Animal Drug Shortages that covers voluntary submissions from spons...