CHMP recommends Revolade for severe aplastic anaemia
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion for Revolade for the treatment of patients with severe aplastic anaemia who have had an insufficient response to IST...
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27 July 2015 | By Victoria White
CHMP has adopted a positive opinion for Revolade for the treatment of patients with severe aplastic anaemia who have had an insufficient response to IST...
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis...
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for on marketing authorisation of Fexeric, recommending its approval for the treatment of hyperphosphatemia in CKD...
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion recommending the approval of Shire’s Intuniv for the treatment of ADHD in children and adolescents...
29 June 2015 | By Victoria White
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation in the EU for CSL Behring's Respreeza...
29 June 2015 | By Victoria White
The CHMP has recommended that the EC approves the use of Perjeta for the neoadjuvant treatment of adult patients with HER2-positive early breast cancer...
29 June 2015 | By Victoria White
The CHMP has issued a positive opinion for the expanded use of Novo Nordisk’s Levemir (insulin detemir) in children with diabetes as young as one year old...
26 June 2015 | By Victoria White
Alexion has announced that the CHMP of the EMA has adopted positive opinions recommending marketing authorisation of Strensiq and Kanuma...
26 June 2015 | By Victoria White
The CHMP of the EMA have adopted a positive opinion for panobinostat capsules for the treatment of patients with multiple myeloma...
26 June 2015 | By Victoria White
CHMP has recommended granting marketing authorisation to Raxone for the treatment of visual impairment in patients with Leber's Hereditary Optic Neuropathy...
4 June 2015 | By Victoria White
AVEO has received confirmation of support from two CHMP members following pre-submission meetings to discuss the potential submission of a MAA for tivozanib...
27 May 2015 | By Victoria White
Helsinn Group has announced that the European Commission has approved ALOXI injection for the prevention of acute CINV in children aged one to six months...
30 March 2015 | By Victoria White
BI and Lilly announce they have received a positive opinion from CHMP, recommending empagliflozin/metformin hydrochloride for the treatment type 2 diabetes...
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
26 January 2015 | By NewCap.
Santen SAS announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of a marketing authorization for Ikervis®...