The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque ...

The approval marks the therapy as the first and only menin inhibitor for treating patients one year and older with relapsed or refractory acute leukaemia with KMT2A ...

Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...

11 1. UCB receives U.S. FDA approval for Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate-to-severe hidradenitis suppurativa. News release. UCB Pharma.

The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of inflammatory rosacea in adults. The extended-release capsules (40 mg ...

The FDA has approved imatinib oral solution (Imkeldi) for the treatment of certain forms of leukemia and other cancers. This is the first oral liquid form of imatinib for the treatment of select ...

The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first-in-class muscarinic agonist, for the treatment of schizophrenia in adults.

Kebilidi is the first FDA-approved gene therapy for the deficiency. PTC shares gained around 8.5 percent in the extended trading on the Nasdaq on Thursday, at $45.97. AADC deficiency is a rare ...

TUESDAY, Nov. 12, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Emrosi (minocycline hydrochloride) for the treatment of inflammatory rosacea in adults. The ...

The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe supraventricular tachycardia (SVT), including atrial fibrillation and ...

Biocon Biologics Ltd. announced today the FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara (ustekinumab) biosimilar, for the treatment of patients with inflammatory bowel disease, plaque ...

Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with aggressive blood cancer acute lymphoblastic leukaemia (ALL). The US ...