IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA)
IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced ...
Vanda Pharmaceuticals Files for New Drug Application for Tradipitant for Motion Sickness Treatment
Vanda Pharmaceuticals Inc. recently made a significant move by filing a new drug application for Tradipitant. The application, targeted at addressing motion sickness, was publicized through a social ...
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Rethinking AI hallucinations: Unlocking new frontiers in drug discovery
Hallucinations in LLMs refer to instances where models generate plausible yet incorrect or unrelated information.
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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
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Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
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FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
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Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on ...
Vanda Pharmaceuticals seeks FDA nod for motion sickness drug
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
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FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...