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Biologics

Genentech sBLA OKd for Tecentriq in Lung Cancer

FDA approves a Genentech sBLA for Tecentriq (atezolizumab) for combination use with carboplatin and etoposide for first-line treatment of adults with ...

Medical Devices

QS Issues at TEI Biosciences

FDA warns TEI Biosciences about Quality System violations in its manufacturing of collagen-based medical devices.

Human Drugs

CGMP Violations at 2 United Exchange Facilities

FDA warns United Exchange about CGMP violations at two facilities producing finished pharmaceuticals.

Medical Devices

Cybersecurity Draft Guidance Clarifications Sought

Two stakeholders request changes to an FDA draft guidance on the content of premarket submissions for managing medical device cybersecurity.

Human Drugs

FDA Issues HIV Drug Development Guidances

FDA issues two guidances to help drug sponsors develop drugs to prevent HIV-infection and to treat HIV in pediatric patients.

Medical Devices

Atreon Orthopedics Rotium Bioresorbable Wick Cleared

FDA clears an Atreon Orthopedics 510(k) for the Rotium Bioresorbable Wick, intended for use in supporting healthy tendon regeneration related to rotat...

Medical Devices

Panel to Consider Neuronix NeuroAD for Alzheimers

FDA asks members of its Neurological Devices Panel to evaluate the safety and effectiveness of Neuronix NeuroAD based on results of a clinical trial t...

Human Drugs

Union Sues AbbVie Over Humira Monopoly

A New York grocery workers union sues AbbVie for colluding to delay entry of a biosimilar version of its Humira in the U.S.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Integra LifeSciences, Mentor Worldwide and Acclarent, Nutra Pharma, Sientra, and United ...

Human Drugs

Stokes Healthcare Recalls Vet Eye Drops

Stokes Healthcare recalls one lot of veterinary-use pilocarpine 0.1% ophthalmic solution because it has been found to contain a higher level of the pr...