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RSS FeedPosted by Michael Wonder on 05 May 2016
European Commission approves Halaven (eribulin mesylate) for treatment of advanced liposarcoma in Europe
5 May 2016 - People with advanced liposarcomas in Europe may now be able to receive Halaven (eribulin mesylate), the first ...
Posted by Michael Wonder on 05 May 2016
Ferring Pharmaceuticals announces approval for Nocdurna, a new therapeutic option for the treatment of adults waking multiple times to urinate at night
3 May 2016 - Ferring Pharmaceuticals today announced that Nocdurna (desmopressin) has received approval in the EU for the symptomatic treatment ...
Posted by Michael Wonder on 04 May 2016
BioMarin announces EMA grants accelerated assessment for cerliponase alfa, experimental treatment for a form of Batten disease
3 May 2016 - BioMarin today announced that the EMA has granted BioMarin's request for accelerated assessment for the planned cerliponase ...
Posted by Michael Wonder on 01 May 2016
Highlights from the CHMP 25-28 April 2016 meeting
29 April 2016 - Six medicines, including one new antibacterial, recommended for authorisation in the EU. ...
Posted by Michael Wonder on 01 May 2016
New medicine to help in the fight against antimicrobial resistance
29 April 2016 - Zavicefta is recommended for approval for patients with limited treatment options. ...
Posted by Michael Wonder on 01 May 2016
New treatment for rare white blood cell cancer
29 April 2016 - Treatment of follicular lymphoma to be added to Gazyvaro’s approved uses. ...
Posted by Michael Wonder on 01 May 2016
Novartis drug Afinitor recommended by CHMP to treat select GI and lung neuroendocrine tumors
29 April 2016 - Novartis today announced that the CHMP of the EMA adopted a positive opinion for Afinitor (everolimus) for the ...
Posted by Michael Wonder on 28 Apr 2016
European Commission approves surgical patch TachoSil (human thrombin/human fibrogen) for use in neurological surgery
27 April 2016 - Takeda today announced that the European Commission has granted an expanded indication for surgical patch TachoSil (human thrombin/human ...
Posted by Michael Wonder on 28 Apr 2016
Patients with advanced metastatic colorectal cancer in Europe now have a new treatment option as Lonsulf (trifluridine/tipiracil) receives EU approval
27 April 2016 - Servier today announced that the European Commission has granted marketing authorization for Lonsurf (trifluridine with tipiracil hydrochloride), ...
Posted by Michael Wonder on 28 Apr 2016
Involving general practitioners in regulatory decisions on medicines
28 April 2016 - EMA workshop with general practitioners and family doctors kicks off strengthened collaboration. ...
Posted by Michael Wonder on 27 Apr 2016
Lilly's Taltz cleared in the EU for plaque psoriasis
27 April 2016 - The European Commission has approved Eli Lilly’s biologic Taltz as a new treatment for moderate to severe ...
Posted by Michael Wonder on 26 Apr 2016
European Commission grants marketing authorization for Gilead’s fixed dose combination Descovy (emtricitabine with tenofovir alafenamide fumarate) for treatment of HIV
25 April 2016 - Gilead Sciences today announced that the European Commission has granted marketing authorization for two doses of Descovy ...
Posted by Michael Wonder on 22 Apr 2016
Integrating patients’ views in clinical studies of anti-cancer medicines
22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology ...
Posted by Michael Wonder on 21 Apr 2016
Applications for new human medicines under evaluation by the CHMP - April 2016 update
20 April 2016 - The EMA has published information on applications for centralised marketing authorisation for human medicines that the agency ...
Posted by Michael Wonder on 15 Apr 2016
Listening to the public’s views on the safety of medicines
15 April 2016 - PRAC adopts rules of procedure on public hearings on selected safety reviews. ...