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Federal Register

Ubrelvy Regulatory Review Period Determined

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Allergans Ubrelvy (ubrogepant), indicated for t...

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Federal Register

Regulatory Review Period for TherOx Downstream System

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx Downstream System, i...

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Human Drugs

Patient Groups Sue Over Drug Cost Rules

Three patient advocacy groups sue HHS and the Centers for Medicare and Medicaid Services over their support for insurance companies and pharmacy benef...

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Human Drugs

Beam To Complete Clinical Hold Studies This Year

Beam Therapeutics says it will complete studies requested by FDA as part of a clinical hold on a Beam-201 cancer treatment IND and submit its response...

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Human Drugs

Multiple Violations at Elite One Source

FDA warns Missoula, MT-based Elite One Source Nutritional Services about dietary supplement CGMP and misbranding violations.

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Medical Devices

Lessons Learned from PPI Case Studies

The Medical Device Information Consortium publishes information from a working group looking at the benefits of and approaches to using patient prefer...

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Human Drugs

FDA Introduces Overdose Prevention Framework

FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.

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Human Drugs

FDA Lifts Hold on Curis Leukemia Study

FDA lifts a partial clinical hold on Curis TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase of the trial.

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Medical Devices

Hamilton Medical Ventilator Recalled

Hamilton Medical recalls its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue with the ventilators...

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Human Drugs

Outlook Resubmits ONS-5010 BLA

Outlook Therapeutics resubmits to FDA a BLA for its ONS-5010 to treat wet age-related macular degeneration.