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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...

Alert on Hyperbaric Oxygen Devices

[ Price : $8.95]

FDA alerts health care providers and facilities about the safe use of hyperbaric oxygen therapy devices following reports of serio...

FDA Broadens Use of Amgens Repatha

[ Price : $8.95]

FDA expands the approved use of Amgens cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major...

Argenx Plans sBLA for Vyvgart in Myasthenia Gravis

[ Price : $8.95]

Argenx says it will seek expanded approval for Vyvgart (efgartigimod alfa-fcab) to include adults with acetylcholine receptor anti...

Vanda Urges Makary to Intercede in Generic Dispute

[ Price : $8.95]

Vanda Pharmaceuticals urges FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generi...