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Human Drugs

StemCyte Study of Cell Therapy Drug Approved

FDA approves a StemCyte IND to conduct a Phase 2 trial of its Allogeneic Human Leukocyte Antigen-Matched Umbilical Cord Blood Mononuclear Stem Cells f...

Medical Devices

Tivic Health Gains Clearance for Sinus Pain Reliever

FDA clears a Tivic Health Systems 510(k) for the ClearUP Sinus Pain Relief, a bioelectronic treatment for sinus pain due to allergic rhinitis.

Human Drugs

Shutdown Causes Endo Litigation Delay

FDA asks the DC federal court to continue a stay on Endos drug bulk compounding suit against it until the government shutdown ends.

Human Drugs

Orphan Exclusivity Working: NORD Report

The National Association for Rare Disorders says a study it commissioned shows that the FDA orphan exclusivity designation is working as intended and ...

Some Drug Prices Up for 2019: Reports

Media accounts say some drug companies are greeting the new year by raising prices on prescription medications.

Human Drugs

Icosapent Ethyl Cuts Ichemic Events: Study

Researchers say the REDUCE-IT study demonstrates that patients with elevated triglyceride levels despite use of statins benefit from receiving 2 g of ...

Human Drugs

SCOTUS to Hear Merck Fosamax Appeal Arguments

The Supreme Court schedules oral arguments in a Merck appeal of a 3rd Circuit decision allowing state failure-to-warn claims involving the companys Fo...

Medical Devices

Bruin Biometrics Pressure Ulcer Scanner Cleared

FDA grants Bruin Biometrics de novo clearance to market the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the sta...

Human Drugs

Suvodirsen Complex Innovative Trial Design

FDA says a Phase 2/3 efficacy trial for Wave Life Sciences DMD drug suvodirsen will be in the agencys pilot program for complex innovative trial desig...

Human Drugs

FDA OKs Expanded Sprycel Indication

FDA approves an expanded indication for Bristol-Myers Squibbs Sprycel (dasatinib) tablets to include treating pediatric patients one year of age and o...