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Axogen Nerve Graft Review Extended by 3 Months

[ Price : $8.95]

FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submit...

11 QS, MDR Violations at Miach Orthopaedics

[ Price : $8.95]

FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its...

BIO September Congressional Priorities

[ Price : $8.95]

The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA ...

Multiple GLP Violations at Chinas Jiangsu Kerbio

[ Price : $8.95]

FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical ...

FDA Breakthrough Status for Lupis Blood Purifier

[ Price : $8.95]

FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, t...

Inovio Begins Rolling BLA for Rare Throat Disorder

[ Price : $8.95]

Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papill...

Chikungunya Vaccine Suspended Due to Safety Concerns

[ Price : $8.95]

CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.

FDA Study: CBD Linked to Elevated Liver Enzymes

[ Price : $8.95]

An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes i...

Priority Review for Gamida sBLA for Omidubicel

[ Price : $8.95]

FDA accepts for priority review a Gamida Cell supplemental BLA for omidubicel and its use in severe aplastic anemia.

Breakthrough Status for Quests Haystack MRD Test

[ Price : $8.95]

FDA grants Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minim...