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De Novo for Antibacterial Coated Implants

[ Price : $8.95]

FDA grants Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants.

Shuffert Debarred for 5 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar for five years Robert Lance Shuffert from importing or offering for import a...

Abecma Expanded Approval for Multiple Myeloma

[ Price : $8.95]

FDA approves a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating ce...

Honeywell Recalls Eyewash Cartridge

[ Price : $8.95]

Honeywell Safety Products recalls its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station due to GMP c...

Accelerated Approval for Enhertu in Solid Tumors

[ Price : $8.95]

FDA grants Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating certain adult patient...

Jubilant Generics Cited Over GMPs

[ Price : $8.95]

FDA issues Jubilant Generics a four-observation Form FDA-483 after inspecting the firms India facility in February.

AbbVie Urges FDA to Ban Unlicensed Thyroid Products

[ Price : $8.95]

AbbVie petitions FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract products.

FDA Seeks Industry Rep for Device Panel

[ Price : $8.95]

Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representa...

Panel to Discuss Pediatric Studies for Cancer Drugs

[ Price : $8.95]

Federal Register notice: FDA announces a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting to...

Withdraw AvertD Approval: Scientists

[ Price : $8.95]

Some 31 experts in genetics, addiction, psychiatry, and medical devices call on FDA to revoke its approval of the AvertD DNA test ...