Medscape Medical News

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
Alert EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma The panel recommends EU approval for duvelisib (Copiktra) for certain patients with chronic lymphocytic leukemia (CLL) or follicular lymphoma.
News, March 29, 2021
Alert First Oral SMA Treatment Gets EMA Panel Thumbs Up The CHMP gives positive opinion on risdiplam as the first oral treatment for adults and children at least 2 months of age who have certain types of spinal muscular atrophy.
News, March 01, 2021
Alert EU Green Light for Dostarlimab in Some Endometrial Cancers A new PD-1 antagonist, dostarlimab, has been recommended for approval for use in some women with advanced/recurrent endometrial cancer.
News, March 01, 2021
Alert EU Panel Backs Icosapent Ethyl for CV Event Reduction Icosapent ethyl, a high-dose marine oil preparation, is already available in the US to reduce cardiovascular events in patients at high CV risk.
News, February 01, 2021
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

No Results