Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.
Regulatory and reimbursement pathways should consider indirect benefits in addition to direct health benefits when evaluating ...
New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025Upon FDA approval, ...
The U.S. health secretary has vowed to close an FDA loophole that has allowed food companies to self-police the safety of new ...
A rise in the use of non-FDA-approved diabetes and obesity medications has spurred health care professionals and medical ...
Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...
The US Food and Drug Administration (FDA) has approved Neffy, a nasal spray for treating severe allergic reactions in children aged 4 and above. This is the first emergency allergy treatment ...
FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must ...
The Food and Drug Administration lets companies self-report whether a chemical they add to food is safe. That may be changing ...
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties ...
The FDA ordered compounding pharmacies to stop making copycat versions of weight loss drugs like Ozempic and Zepbound now ...
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