Blog
RSS FeedPosted by Michael Wonder on 13 Nov 2016
U.S. FDA approves Gilead’s Vemlidy (tenofovir alafenamide fumarate) for the treatment of chronic hepatitis B virus infection
10 November 2016 - Vemlidy is a once-daily treatment that demonstrated similar efficacy with improved renal and bone laboratory safety ...
Posted by Michael Wonder on 13 Nov 2016
Highlights from CHMP November 2016 meeting
11 November 2016 - Nine medicines recommended for approval, including three biosimilars. ...
Posted by Michael Wonder on 02 Nov 2016
Health Canada approves Alecensaro - a targeted oral treatment - for patients with aggressive and rare form of lung cancer
31 October 2016 - Early data suggests Alencensaro also shows strong efficacy in treating the spread of lung cancer to ...
Posted by Michael Wonder on 31 Oct 2016
Alprolix approved in Switzerland for the treatment of haemophilia B
28 October 2016 - Alprolix approved in Switzerland for the treatment of haemophilia B ...
Posted by Michael Wonder on 31 Oct 2016
TGA approves new combination product for type 2 diabetes
31 October 2016 - The TGA has approved AstraZeneca's Qtern (saxagliptin hydrochloride with dapagliflozin propanediol monohydrate). ...
Posted by Michael Wonder on 31 Oct 2016
TGA approves yet another use for Humira (adalimumab)
31 October 2016 - AbbVie clocks up another indication for its TNF-alfa inhibitor. ...
Posted by Michael Wonder on 30 Oct 2016
Roche announces FDA approval for Ventana PD-L1 (SP142) assay to support immunotherapy treatment decisions in lung cancer
27 October 2016 - First FDA-approved test to support patient treatment decisions for Tecentriq (atezolizumab) in non-small-cell lung cancer. ...
Posted by Michael Wonder on 29 Oct 2016
FDA approves new device for prevention of recurrent strokes in certain patients
28 October 2016 - The U.S. FDA today approved the Amplatzer PFO Occluder device. ...
Posted by Michael Wonder on 29 Oct 2016
Sanofi and Regeneron receive complete response letter from FDA for sarilumab, an investigational treatment for rheumatoid arthritis
28 October 2016 - Sanofi and Regeneron Pharmaceuticals today announced the U.S. FDA issued a complete response letter regarding the ...
Posted by Michael Wonder on 26 Oct 2016
First and only medication approved in Canada for the treatment of binge eating disorder
25 October 2016 - Vyvanse (lisdexamphetamine dimesylate) now indicated for the treatment of moderate to severe binge eating disorder ...
Posted by Michael Wonder on 25 Oct 2016
FDA approves Merck’s Keytruda (pembrolizumab) in metastatic NSCLC for first-line treatment of patients whose tumours have high PD-L1 expression (tumour proportion score of 50 percent or more) with no EGFR or ALK genomic tumour aberrations
25 October 2016 - FDA also approves a labeling Update for Keytruda for the treatment of patients with metastatic NSCLC ...
Posted by Michael Wonder on 24 Oct 2016
FDA approves supplemental new drug application for Xtandi in advanced prostate cancer
24 October 2016 - Astellas and Pfizer today announced the U.S. FDA approved a supplemental new drug application to update the ...
Posted by Michael Wonder on 24 Oct 2016
FDA approves Merck’s Zinplava (bezlotoxumab) to reduce recurrence of Clostridium difficile Infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk of CDI recurrence
24 October 2016 - Merck today announced that the U.S. FDA has approved Zinplava (bezlotoxumab) 25 mg/mL solution for injection. ...
Posted by Michael Wonder on 21 Oct 2016
FDA official warns other drug makers not to copy Sarepta
20 October 2016 - Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval ...
Posted by Michael Wonder on 19 Oct 2016
FDA approves Lilly's Lartruvo (olaratumab) in combination with doxorubicin for soft tissue sarcoma
19 October 2016 - Lartruvo received the FDA's breakthrough therapy designation and was approved under the Agency's accelerated approval program. ...