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RSS FeedPosted by Michael Wonder on 22 Nov 2016
Allergan announces receipt of additional Health Canada approval for Fibristal
21 November 2016 - Allergan announced that it has received an additional approval from Health Canada for Fibristal (ulipristal acetate, 5 ...
Posted by Michael Wonder on 22 Nov 2016
Genmab announces U.S. FDA approval of Darzalex (daratumumab) for relapsed multiple myeloma
21 November 2016 - Darzalex (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for ...
Posted by Michael Wonder on 21 Nov 2016
Teva secures European approval of Trisenox for first-line treatment of low to intermediate risk acute promyelocytic leukaemia
21 November 2016 - Decision solely based on published academic data endorsing the benefit of Trisenox as first chemotherapy-free treatment for ...
Posted by Michael Wonder on 21 Nov 2016
GSK receives FDA approval for expanded indication for FluLaval Quadrivalent (influenza vaccine) for infants 6 months and older
18 November 2016 - GSK announced today it has received approval from the US FDA Center for Biologics Evaluation and ...
Posted by Michael Wonder on 20 Nov 2016
TGA approves Grifols' Prolastin C
17 November 2016 - The TGA has approved Grifols' new alfa-1-proteinase inhibitor. ...
Posted by Michael Wonder on 19 Nov 2016
Spectrum Pharmaceuticals says FDA rejects its bladder cancer drug
18 November 2016 - Spectrum Pharmaceuticals said on Friday the U.S. FDA had rejected its bladder cancer treatment, apaziquone. ...
Posted by Michael Wonder on 17 Nov 2016
FDA approves Intrarosa for postmenopausal women experiencing pain during sex
17 November 2016 - The U.S. FDA approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse ...
Posted by Michael Wonder on 17 Nov 2016
TGA approves Ninlaro
17 November 2016 - The TGA has approved Takeda's proteasome inhibitor for use by patients with multiple myeloma. ...
Posted by Michael Wonder on 16 Nov 2016
European Commission approves Stelara (ustekinumab) for treatment of adults with moderately to severely active Crohn’s disease
11 November 2016 - First interleukin 12/23 inhibitor licensed for Crohn’s disease. ...
Posted by Michael Wonder on 15 Nov 2016
STADA receives “positive opinion” from the EMA for teriparatide biosimilar
14 November 2016 - As expected and within the scope of the current EU-wide approval procedure, STADA Arzneimittel AG on November ...
Posted by Michael Wonder on 15 Nov 2016
Once-daily anticoagulant Lixiana (edoxaban tosylate) approved in Canada for stroke prevention in atrial fibrillation and for the treatment and prevention of recurrent deep-vein thrombosis and pulmonary embolism
9 November 2016 - Servier Canada announced today that Lixiana (edoxaban tosylate) has been approved by Health Canada for the two ...
Posted by Michael Wonder on 14 Nov 2016
European Commission approves Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adults on haemodialysis
11 November 2016 - First treatment advance for secondary hyperparathyroidism in more than a decade and first intravenous calcimimetic to ...
Posted by Michael Wonder on 14 Nov 2016
AbbVie's Humira (adalimumab) receives CHMP positive opinion to treat adolescents with hidradenitis suppurativa, a chronic inflammatory skin disease
14 November 2016 - If approved by the European Commission, Humira will be the first and only treatment option for ...
Posted by Michael Wonder on 14 Nov 2016
CHMP recommendation for CSL's Afstyla (rFVIII-SC)
14 November 2016 - CSL today announced that the EMA's CHMP has recommended granting marketing authorisation for CSL Behring’s Afstyla [recombinant ...
Posted by Michael Wonder on 14 Nov 2016
Novartis drug PKC412 (midostaurin) granted FDA priority review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis
14 November 2016 - The AML treatment strategy has remained unchanged for more than 25 years and PKC412 (midostaurin) may ...