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Sutro Biopharma Orphan Status for Multiple Myeloma Therapy

[ Price : $8.95]

FDA grants Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma.

Panel Gives Mixed Vote on Trevena Pain Drug

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 8 to 7 to recommend not approving Trevenas next-generation op...

Require High-Quality Device Evidence: Blog

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Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medic...

Generic Drug Approvals Set New Record

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The CDER Office of Generic Drugs sets a new record for generic drug approvals.

TransEnterix Gains Clearance for Smaller Surgery Instruments

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FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparosco...

Boehringer sNDA for Broader Stiolto Respimat Label OKd

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FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) ...

Safety Alert on Medtronic Cybersecurity Software Fix

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FDA issues a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associat...

Ban Uncontained Power Morcellators: Petition

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Surgeon and anti-power morcellator activist Hooman Noorchashm petitions FDA to ban uncontained laparoscopic power morcellators use...

Webinar Explains Indication, Usage Guidance

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CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content...

FDA $5 Million Grant to Spur Pediatric Device Development

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FDA awards $5 million to the National Capital Consortium for Pediatric Device Innovation, led by Children's National Health System...