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FDA planning new guidance, hires in cell and gene therapies for...

The FDA plans to hire at least 50 new clinical reviewers tasked with assessing cell and gene therapies to prepare for what the agency...

Recon: FDA Staff Unfazed by CV Signal in Amgen’s Osteoporosis Trials;...

Posted 14 January 2019 | By Michael Mezher  ...

FDA starts more unpaid work as shutdown enters week 4

The FDA has expanded the list of activities it expects staff to perform without being paid during the government shutdown. FDA Commissioner Scott...

FDA approves Abbott’s pea-sized implant for sealing congenital heart defects in...

Abbott has received FDA approval for its Amplatzer Piccolo Occluder, which the medtech giant describes as the world’s first implant designed for babies...

FDA clears Ossio’s integrative mineral bone pins for orthopedic surgeries

The FDA has granted a 510(k) clearance to Ossio for its family of bio-integrative bone pins, which secure broken bones during the healing...

New FDA Plan Focuses on Plant and Animal Biotechnology

The plan’s key components are intended to ensure the safety of plant and animal biotechnology products. A December 3 informational webinar is planned.The...

FDA shutdown no foil for Aimmune’s peanut allergy drug, but holds...

SAN FRANCISCO—Concerned about a government shutdown, Aimmune took care to file the BLA for its oral immunotherapy for peanut allergy by Dec. 21....

FDA reduces inspections, putting food supply at risk, as shutdown continues...

As the partial shutdown of the U.S. government continues, many of the government's food safety inspection duties have been curtailed. The Food and Drug...

Amgen gets first OK for Evenity in Japan as FDA panel...

Amgen will head into its FDA advisory committee meeting for new osteoporosis drug Evenity next week comforted by a first approval for the...

Withings unveils $129 Move ECG smartwatch with ECG monitoring that is...

Valentina Palladino / Ars Technica: Withings unveils $129 Move ECG smartwatch with ECG monitoring that is awaiting FDA clearance, activity and sleep tracking,...

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