Medscape Medical News

Alert EU Green Light for Finerenone for CKD, Growth Hormone for Kids Positive opinions issued for branded somatrogon and finerenone and for generic versions of sitagliptin/metformin hydrochloride and sapropterin.
News, December 20, 2021
Alert EMA Panel Backs Linzagolix for Uterine Fibroid Symptoms Linzagolix is an oral gonadotropin-releasing hormone antagonist for the management of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
News, December 20, 2021
Alert Anifrolumab (Saphnelo) Gets Green Light for Approval in EU Anifrolumab, a monoclonal antibody against type I interferon receptor, was approved by the US Food and Drug Administration in July 2021.
News, December 18, 2021
Alert EMA Panel Endorses Two Cancer Drugs, One Sickle Cell Drug The recommendations from the European Medicines Agency panel mean the drugs will likely be approved soon.
News, December 17, 2021
Alert Diroximel Fumarate (Vumerity) Cleared for MS in Europe Diroximel fumarate is similar to dimethyl fumarate (Tecfidera) in efficacy but has a unique chemical structure that may induce less GI irritation.
News, November 17, 2021
Alert EU Green Light for Once-Weekly Growth Hormone for Kids A long-acting, once-weekly formulation of human growth hormone, lonapegsomatropin, nears approval in the EU for growth failure in kids aged 3 to 18 years.
News, November 16, 2021
Alert Europe Gives Green Light to Once-Weekly Semaglutide for Weight Loss Called a 'game changer,' Novo Nordisk's Wegovy was approved for weight loss by the US Food and Drug Administration in June.
News, November 16, 2021
EMA Panel Backs Uplizna for Neuromyelitis Optica The immunosuppressant inebilizumab is indicated to treat adults with neuromyelitis optica spectrum disorder who are anti-aquaporin 4 immunoglobulin G seropositive.
News, November 15, 2021
Alert EU Panel Endorses First-of-Its-Kind Lung Cancer Drug Sotorasib is the first drug to successfully target KRAS mutations in non-small cell lung cancer.
News, November 15, 2021
Alert EMA Recommends VAXNEUVANCE Pneumococcal Vaccine for Approval The vaccine, which received FDA approval in July, protects against 15 strains of Streptococcus pneumoniae.
News, October 15, 2021
Alert EU Panel Likes Two Cancer Drugs, Drops One Two new cancer drugs were recommended for approval, and one had its marketing authorization withdrawn at the October meeting of the European Medicines Agency's advisory panel.
News, October 15, 2021
Alert European Agency Recommends Two New Adalimumab Biosimilars The Committee for Medicinal Products for Human Use gave a positive opinion for the approval of Hukyndra and Libmyris, each of which will have 15 indications.
News, September 17, 2021
Alert EMA Endorses Injectable Malaria Drug Artesunate The drug, which was approved by the FDA last year, is an initial treatment of severe malaria in adults and children.
News, September 17, 2021
Alert Flurry of Cancer Drug Endorsements From EU Panel The European Medicines Agency panel recommended for approval three new cancer drugs and additional indications for two other already marketed immunotherapies.
News, September 17, 2021
Alert EU Green Light for Roxadustat in Anemia of Kidney Disease European Medicines Agency committee issues a positive opinion for roxadustat, which would be the first orally administered treatment for adults with CKD-associated anemia.
News, June 29, 2021
EMA Panel OKs Two New Drugs for Blood Cancers The CHMP has recommended conditional marketing authorization for idecabtagene vicleucel for multiple myeloma and tafasitamab for lymphoma.
News, June 28, 2021
Alert EU Panel Likes Monotherapy Cemiplimab for Two Cancers In Europe, the Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for cemiplimab as monotherapy in lung cancer and basal cell carcinoma.
News, May 25, 2021
Alert EU Panel Likes Azacitidine for AML Maintenance The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion of the drug for use as maintenance therapy in patients with acute myeloid leukemia.
News, April 23, 2021
Alert Cannabidiol Cleared for Tuberous Sclerosis Complex in Europe The European Commission has approved cannabidiol for seizures associated with tuberous sclerosis complex in patients aged 2 years and older, marking the third indication in Europe.
News, April 20, 2021
Alert Europe Approves Pemigatinib for Bile Duct Cancer The oral targeted therapy is for the treatment of locally advanced or metastatic cholangiocarcinoma.
News, March 31, 2021

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