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Keytruda Plus Chemo Approved for Cervical Cancer

[ Price : $8.95]

FDA approves Mercks Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with pers...

Some Class 1 Devices Exempt from UDI

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Reg...

Guide on Drug Continuous Manufacturing

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Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Pr...

Revance Therapeutics FDA-483 Released

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FDA releases the FDA-483 with five inspection observations issued following an inspection at Revance Therapeutics.

Otsuka/H. Lundbeck sNDA for Rexulti in Adolescents

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FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating...

Embozene Breakthrough for Knee Osteoarthritis

[ Price : $8.95]

FDA grants Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization in treating sy...

FDA Posts Guide on Drug Continuous Manufacturing

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FDA posts a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.

3 Hand Sanitizer Guidances Withdrawn

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Federal Register notice: FDA withdraws three guidance documents on hand sanitizer products because consumers and healthcare person...

Delphinus PMA OKd for Breast Screener

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FDA approves a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjun...

Advisors to Consider Moderna Vaccine Booster

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The FDA Vaccines and Related Biological Products Advisory Committee will consider 10/14 Modernas request for an EUA for a Covid va...