AstraZeneca Lokelma recommended for approval in EU for patients with hyperkalaemia on stable haemodialysis Medical Dialogues Bureau31 March 2020 1:05 PM ISTLokelma is a highly selective, oral potassium-removing agent currently approved in the US, EU, Canada, Hong Kong, China, Russia, and Japan for the...
EMA accepts GSK filing for Trelegy Ellipta use in adults with asthma Medical Dialogues Bureau4 March 2020 10:15 AM ISTonce-daily single inhaler triple therapy available for asthma and COPD if approved
Novartis announces FDA and EMA filing acceptance of ofatumumab, for treatment of relapsing form of MS Medical Dialogues Bureau25 Feb 2020 1:03 PM IST"With ofatumumab, we underpin our relentless dedication to reimagining medicine for patients across the MS spectrum and will work closely with the...
AbbVie gets positive CHMP Opinion for VENCLYXTO for Leukemia patients Medical Dialogues Bureau8 Feb 2020 10:00 AM ISTNew Delhi: AbbVie , a research-based global biopharmaceutical company, announced recently that the Committee for Medicinal Products for Human Use...
Bayer makes EMA application for a pre-filled syringe to administer eye medication Eylea MD bureau2 Feb 2020 10:00 AM ISTBerlin: Bayer has submitted an application to the European Medicines Agency (EMA) for a pre-filled syringe to administer Eylea® (aflibercept solution...
USFDA to review Sanofi isatuximab for treatment of multiple myeloma Medical Dialogues Bureau21 July 2019 9:15 AM ISTSanofi Isatuximab targets a specific epitope on the CD38 receptor. It is designed to trigger multiple, distinct mechanisms of action that are believed...
Tighter EU rules could trigger antibiotic shortage; says Fresenius Medical Dialogues Bureau9 Jun 2019 9:00 AM ISTFresenius said that under the draft proposals, the bulk-freeze-dryers that is used to produce the antibiotic would have to be sterilised more...
Pfizer acquires clinical-stage Biotech Therachon for $810 million Garima12 May 2019 9:45 AM ISTNEW YORK: Pfizer recently announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately...
Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer Farhat Nasim29 April 2019 9:35 AM ISTThe positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan Farhat Nasim13 March 2019 1:49 PM ISTValsartan, sold under the trade name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney...
GSK's severe pediatric asthma drug wins European panel thumbs-up Ruby Khatun Khatun30 July 2018 10:00 AM ISTGlaxoSmithKline (GSK) drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with...
EMA accepts marketing authorization applications of Mylan and Biocon for 2 biosimilars Ruby Khatun Khatun2 Dec 2017 10:00 AM ISTHERTFORDSHIRE, England, PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for...
