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.

An extension was required to provide the FDA time to review additional sensitivity analyses of clinical efficacy data from the TRANSCEND trial.

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.

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 — 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 — 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 — 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.

Any aspirin use linked to lower hazards of MI, ischemic stroke, with greater benefit in high-frequency use group ...

HealthDay News — Two human leukocyte antigen (HLA) class I alleles are independently associated with an increased risk for allopurinol-induced severe cutaneous adverse reactions (SCARs), according to ...

HealthDay News — A growing Listeria outbreak linked to recalled pasta meals has now sickened 27 people and caused 6 deaths across 18 states, according to new data from the US Centers for Disease ...

Dr George Tidmarsh, who joined the FDA in July, stepped down Sunday, The New York Times reported. His resignation came just days after he was placed on administrative leave while federal officials ...