Blog
RSS FeedPosted by Michael Wonder on 26 Sep 2016
US FDA approves labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia
24 September 2016 - Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance ...
Posted by Michael Wonder on 24 Sep 2016
CADTH publishes final recommendation for Lenvima (lenvatinib mesylate)
20 September 2016 - CADTH has posted its final outcome for Eisai's Lenvima. ...
Posted by Michael Wonder on 24 Sep 2016
FDA approves Amgen's Amjevita (adalimumab-atto) for treatment of seven inflammatory diseases
23 September 2016 - First biosimilar adalimumab approved by FDA. ...
Posted by Michael Wonder on 23 Sep 2016
EU approves Allergan’s IBS drug
23 September 2016 - European regulators have issued approved Allergan's Truberzi, giving patients potential access to the first approved treatment for ...
Posted by Michael Wonder on 23 Sep 2016
NICE says yes to another hepatitis C drug
23 September 2016 - A new drug which effectively treats more genotypes of hepatitis C has been recommended for use in ...
Posted by Michael Wonder on 22 Sep 2016
The FDA did the right thing by approving a novel drug for a disabling disease
22 September 2016 - The FDA’s leadership did the right thing, according to Elaine Schattner in Forbes magazine. ...
Posted by Michael Wonder on 22 Sep 2016
NICE to recommend new drug to treat rare inherited bone disorder in children
22 September 2016 - NICE recommends ‘lifeline’ drug for babies and young children, in draft guidance. ...
Posted by Michael Wonder on 20 Sep 2016
Did the FDA set ‘a dangerous precedent’ with its latest drug approval?
19 September 2016 - The experimental drug that the FDA approved Monday will only be used by a few thousand patients. ...
Posted by Michael Wonder on 20 Sep 2016
Behind the Sarepta drug approval was intense FDA bickering
19 September 2016 - The run-up to this week's approval of a Sarepta Therapeutics medicine to treat patients with Duchenne muscular ...
Posted by Michael Wonder on 20 Sep 2016
FDA approves new five-year-contraceptive of Bayer
19 September 2016 - The U.S. FDA has approved Bayer AG’s new low dose levonorgestrel-releasing intrauterine system which will be marketed ...
Posted by Michael Wonder on 19 Sep 2016
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
19 September 2016 - The U.S. FDA today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with ...
Posted by Michael Wonder on 19 Sep 2016
Talimogene laherparepvec in melanoma: additional clinical benefit not proven
15 September 2016 - Drug manufacturer dossier contained no data suitable for the assessment. ...
Posted by Michael Wonder on 19 Sep 2016
NICE says no to expanding scope of Roche’s IPF drug
19 September 2016 - Patients in England and Wales with the lung scarring disease idiopathic pulmonary fibrosis will have to wait ...
Posted by Michael Wonder on 17 Sep 2016
Takeda receives positive CHMP opinion for conditional approval of Ninlaro (ixazomib), the first oral proteasome inhibitor, for use in patients with multiple myeloma
16 September 2016 - If authorised, Ninlaro will provide a new treatment option for European patients with multiple myeloma who have ...
Posted by Michael Wonder on 17 Sep 2016
Amgen receives positive CHMP opinion for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis
16 September 2016 - Novel treatment administered intravenously would put delivery of important therapy in the hands of the health care ...