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Liquidia says it believes there no longer are legal bars on FDA approving its Yutrepia inhalation powder for two indications.[ Price : $8.95]
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for slowing disea...[ Price : $8.95]
Hogan Lovells attorneys say FDA may create new Centers of Excellence as it works to regulate AI in medical product development thr...[ Price : $8.95]
The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califf...[ Price : $8.95]
Amylyx Pharmaceuticals withdraws the approval of its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurur...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled New Dietary Ingredient Notification Master Files for Dietar...[ Price : $8.95]
Smiths Medical recalls its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may malfunctio...[ Price : $8.95]
A Sidley petition comment response asks FDA to disregard comments on Sidleys orphan drug exclusivity petition made by former FDA o...