An extension was required to provide the FDA time to review additional sensitivity analyses of clinical efficacy data from the TRANSCEND trial.
The approval for HR-SMM was based on data from the phase 3 AQUILA study, which evaluated Darzalex Faspro in adults aged 31 years and older with HR-SMM.
FDA restrict the sale of unapproved fluoride products; the AAP statement on leucovorin in ASD; at-home prenatal ultrasound; Kygevvi approved; Gazyva reduces SLE disease activity.
Two major drugmakers will slash the price of popular weight loss medications for some Americans, including people on Medicare and Medicaid, President Donald Tru ...
An extension was required to provide the FDA time to review additional sensitivity analyses of clinical efficacy data from the TRANSCEND trial.
The Food and Drug Administration (FDA) has approved Caplyta ® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The Food and Drug Administration (FDA) has approved Linzess ® (linaclotide) for the treatment of irritable bowel syndrome with constipation (IBS-C) in patients 7 years of age and older. Previously, ...
HealthDay News — The Maldives has become the first country in the world to ban tobacco use for an entire generation, after a new law took effect Saturday.
HealthDay News — Serial adjunctive ketamine infusions are not more effective than serial midazolam infusions in reducing depressive symptoms in patients receiving inpatient psychiatric care for a ...
HealthDay News — A first-of-its-kind clinical trial is beginning in the US to see if pig kidneys could help save the lives of people waiting for a human organ transplant.
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Biohaven regarding the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ...
The decision to discontinue production was driven by business considerations rather than concerns about the product’s safety or effectiveness.
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