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September 20, 2021

FDA Approves Ranibizumab Biosimilar FDA Approves Ranibizumab Biosimilar

The US Food and Drug Administration (FDA) has approved the first biosimilar for ophthalmology, Byooviz (ranibizumab-nuna), which will be indicated for neovascular (wet) age-related macular degeneration […]
September 17, 2021

European Agency Recommends Two New Adalimumab Biosimilars European Agency Recommends Two New Adalimumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris. The biosimilars, […]
September 17, 2021

FDA Panel Backs Pfizer’s COVID Booster for 65 and Older, High Risk FDA Panel Backs Pfizer’s COVID Booster for 65 and Older, High Risk

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. A US Food and Drug Administration (FDA) advisory panel voted unanimously today […]
September 17, 2021

EMA Endorses Injectable Malaria Drug Artesunate EMA Endorses Injectable Malaria Drug Artesunate

The European Medicines Agency’s human medicines committee has recommended approval for an intravenous treatment for severe malaria. The Committee for Medical Products for Human Use (CHMP) […]
September 17, 2021

Flurry of Cancer Drug Endorsements From EU Panel Flurry of Cancer Drug Endorsements From EU Panel

Three new cancer drugs have been recommended for approval in Europe, as well as new indications for two already marketed immunotherapies. The positive opinions were issued […]
September 16, 2021

As Opioid Deaths Climb, Human Trials Begin for Vaccine As Opioid Deaths Climb, Human Trials Begin for Vaccine

Opioid-related drug overdose deaths in the United States exploded to an estimated record high of 69,031 people in 2020, topping the 49,860 deaths logged in 2019, […]
September 1, 2021

Three JAK Inhibitors Get Boxed Warnings, Modified Indications Three JAK Inhibitors Get Boxed Warnings, Modified Indications

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood […]
September 1, 2021

FDA Approves First Twice-Yearly Antipsychotic for Schizophrenia FDA Approves First Twice-Yearly Antipsychotic for Schizophrenia

The US Food and Drug Administration (FDA) has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the […]
August 27, 2021

FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab

The US Food and Drug Administration (FDA) has approved the Vivistim System (MicroTransponder), a first-of-its kind vagus nerve stimulation (VNS) system intended to treat moderate-to-severe upper […]
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