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ReCor Medical Breakthrough for Hypertension Device

[ Price : $8.95]

FDA grants ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treati...

3 New Device Guides for Performance-Based Pathway

[ Price : $8.95]

FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.

X4 Pharma Gets Rare Pediatric Disease Status

[ Price : $8.95]

FDA grants X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia...

FDA Accepts Atox Bio NDA Filing for Reltecimod

[ Price : $8.95]

FDA accepts for filing an Atox Bio NDA for reltecimod to treat patients with necrotizing soft tissue infections.

Researchers Find No Excess Deaths in Paclitaxel-Coated Devices

[ Price : $8.95]

Swedish researchers say they found no significant increase in the risk of death in patients who received paclitaxel-coated devices...

FDA Withdrawing Approval of Allergans Asacol

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delay...

FDA Performance Review Board Members Announced

[ Price : $8.95]

Federal Register notice: FDA announces the names of the members who will serve on its fiscal year 2020 Performance Review Board.

ICH eCTD Document Q&A at Step 4

[ Price : $8.95]

The International Council on Harmonization says its electronic Common Technical Document question-and-answer document has reached ...

FDA Authorizes 1st Covid DTC Test

[ Price : $8.95]

FDA authorizes the first non-prescription DTC Covid-19 test kit.

FDA/Industry PDUFA 7 Discussions Updated

[ Price : $8.95]

FDA releases summaries from two PDUFA 7 reauthorization negotiation meetings.