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June 18, 2020

FDA Approves Cosentyx for Treatment of Active nr-axSpA FDA Approves Cosentyx for Treatment of Active nr-axSpA

The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis. FDA approval was […]
June 18, 2020

FDA Approves Lilly’s Ultra-Rapid-Acting Insulin, Lyumjev FDA Approves Lilly’s Ultra-Rapid-Acting Insulin, Lyumjev

The US Food and Drug Administration has approved rapid-acting insulin lispro-aabc injection 100 and 200 units/mL (Lyumjev, Eli Lilly) for the treatment of adults with type […]
June 16, 2020

FDA Approves Video Game-Based Therapy for Kids With ADHD FDA Approves Video Game-Based Therapy for Kids With ADHD

The US Food and Drug Administration (FDA) has allowed marketing of a “prescription-only game-based” digital therapeutic device for children aged 8 to 12 years who have […]
June 16, 2020

Lurbinectedin (Zepzelca) Approved for Metastatic SCLC Lurbinectedin (Zepzelca) Approved for Metastatic SCLC

Patients with metastatic small cell lung cancer (SCLC) whose disease has progressed after or during treatment with platinum-based chemotherapy now have a new option to try […]
June 16, 2020

FDA Approves Added Safety Info for Brolucizumab (Beovu) Label FDA Approves Added Safety Info for Brolucizumab (Beovu) Label

The US Food and Drug Administration (FDA) approved a label update for brolucizumab (Beovu, Novartis) that will include additional safety information regarding retinal vasculitis and retinal […]
June 15, 2020

FDA Revokes Emergency Use of Hydroxychloroquine FDA Revokes Emergency Use of Hydroxychloroquine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) revoked its decision from March […]
June 15, 2020

FDA OKs First Dispersible Form of Dolutegravir for Infants FDA OKs First Dispersible Form of Dolutegravir for Infants

The US Food and Drug Administration (FDA) has approved the first dispersible tablet formulation of dolutegravir (Tivicay PD, ViiV Healthcare) to treat HIV-1 infection in children […]
June 15, 2020

Three-Drug Combo Promising Against High-Risk CLL Three-Drug Combo Promising Against High-Risk CLL

For patients with high-risk chronic lymphocytic leukemia (CLL), first-line therapy with a triple combination of targeted agents showed encouraging response rates in the phase 2 CLL2-GIVe […]
June 13, 2020

‘Biosimilar’ Insulin Glargine, Semglee, Approved for Diabetes in US ‘Biosimilar’ Insulin Glargine, Semglee, Approved for Diabetes in US

Semglee, a long-acting human insulin analogue, has been approved for glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes, the […]
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