Medscape Medical News

Alert EMA Panel Endorses Approval of Five New Cancer Drugs The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization or has given a positive opinion regarding several cancer therapies.
News, December 14, 2020
EMA Panel Backs Roclanda Eyedrops, New Option for Glaucoma The fixed-dose combination of latanoprost and netarsudil is for adults with primary open-angle glaucoma or ocular hypertension for whom monotherapy fails.
News, November 16, 2020
Alert EMA Panel Backs Xofluza for Influenza, Post-Exposure Prophylaxis Xofluza (baloxavir marboxil) cuts the duration of influenza-related symptoms and reduces infections when given as post-exposure prophylaxis.
News, November 16, 2020
Alert EMA Recommends First Long-Acting Injectable HIV Treatment Instead of taking daily pills, patients would get intramuscular injections monthly or bimonthly. Pivotal trials show only mild potential side effects for the drugs, which help block replication of the virus.
News, October 19, 2020
Alert EMA OKs First CAR T-Cell Therapy for Mantle Cell Lymphoma Brexucabtagene autoleucel (Tecartus) is a new cell therapy product and the only one with an indication for this particular hematological malignancy.
News, October 16, 2020
New FreeStyle Libre Glucose Monitoring System Gets EU Approval Next-generation FreeStyle Libre 3 is 70% smaller than the previous version, at same cost.
News, October 02, 2020
Alert EMA Panel Backs Baricitinib for Moderate-to-Severe Atopic Dermatitis Baricitinib (Olumiant) would be the first JAK inhibitor (and oral medicine) indicated for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
News, September 22, 2020
Alert EMA Backs Dexamethasone for Severe COVID-19 After Data Review Dexamethasone can be considered a treatment option for adults and adolescents with SARS-CoV-2 infection who require supplemental oxygen therapy.
News, September 18, 2020
Alert EMA Backs Dapivirine Vaginal Ring for HIV Prevention Outside of EU The action is being called a milestone toward expanding the number of biomedical HIV prevention options available to women in sub-Saharan Africa.
News, July 29, 2020
Alert EMA Green Light for Avapritinib for GIST, Acalabrutinib for CLL The European Committee for Medicinal Products for Human Use has given a favorable opinion on both drugs, paving the way for EU approval.
News, July 27, 2020
Alert CHMP Backs Bupivacaine/Meloxicam (Zynrelef) for Postop Pain The CHMPS has recommended granting marketing authorization for the nonopioid drug to treat surgical pain, as well as for a generic form of Fampyra to treat multiple sclerosis associated with walking disability.
News, July 24, 2020
Alert EU Gives Thumb Up for Belantamab in R/R Multiple Myeloma The first-in-class drug belantamab mafodotin (Blenrep) has been recommended for conditional approval in Europe for use in relapsed and refractory multiple myeloma.
News, July 24, 2020
Alert EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease The CHMP has recommended approval for the SGLT2 inhibitor canagliflozin (Invokana) be extended to include diabetic kidney disease.
News, June 01, 2020
Alert EU Panel Backs Triple Combo Asthma Inhaler With Digital Sensor Enerzair Breezhaler combines indacaterol, glycopyrronium, and mometasone and comes with an optional digital sensor that collects data on patient use to support adherence.
News, May 06, 2020
Alert Sanofi's Biosimilar Insulin Aspart Gets Green Light in EU Biosimilar of fast-acting mealtime insulin aspart is given positive opinion by CHMP.
News, May 05, 2020
Alert EU Panel OKs Glasdegib for AML and Luspatercept for MDS Glasdegib has been recommended for approval in Europe for acute myeloid leukemia, and luspatercept has been recommended for anemia associated with myelodysplastic syndromes.
News, May 01, 2020
EMA Panel Backs Pretomanid for Drug-Resistant TB Pretomanid FGK, in combination with bedaquiline and linezolid, is for adults with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis.
News, March 31, 2020
Alert EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly Fluad Tetra induces an immune response similar to that of the adjuvanted trivalent vaccine, with the added benefit of potentially protecting against both circulating type B viruses, the EMA said.
News, March 31, 2020
Alert EMA Panel Backs Zolgensma Gene Therapy for SMA Zolgensma is a gene therapy that addresses the genetic root cause of spinal muscular atrophy by replacing the defective or missing SMN1 gene to halt disease progression.
News, March 27, 2020
Alert EMA Panel Backs Two Antibacterials The EMA panel recommended approval of cefiderocol for infections due to aerobic Gram-negative organisms and of a generic of tigecycline for complicated skin, soft tissue, and intraabdominal infections.
News, March 02, 2020

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