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4 Observations in Suretec Inspection

[ Price : $8.95]

FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.

No Quality Unit Seen in Safrel Pharmaceuticals Inspection

[ Price : $8.95]

FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

FDA Issues Complete Response Letter for Xspray Pharmas Dasynoc

[ Price : $8.95]

FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.

Ultragenyx Gene Therapy OKd for Glycogen Storage Disease

[ Price : $8.95]

FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...

Profound Validation Gap in AI Medical Devices: Study

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Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...

FDA OKs Regeneron Therapy for Fibrodysplasia Ossificans Progressiva

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FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) i...

Draft Guidance on Potency Testing for Active Immunotherapy Products

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FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...

Repeat CGMP Violations at K.C. Pharmaceuticals

[ Price : $8.95]

FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.

Keytruda Melanoma Combination Trial Met Endpoints

[ Price : $8.95]

Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.

Auriga Research CGMP Violations

[ Price : $8.95]

FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.