Blog
RSS FeedPosted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 24 Feb 2019
Shionogi receives European Union Marketing Authorisation for lusutrombopag for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures
22 February 2019 - The approval of lusutrombopag is based on two pivotal Phase 3 randomised clinical trials, L-PLUS1 and L-PLUS2. ...
Posted by Michael Wonder on 24 Oct 2018
International agencies crackdown on fake medicines
24 October 2018 - From 10 to 11 October 2018, the Australian Border Force and the Therapeutic Goods Administration took ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...
Posted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review. ...
Posted by Michael Wonder on 22 Feb 2018
FDA acceptance of Medicines360's filing for supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg
22 February 2018 - Application seeks to extend duration of use up to 5 years for Liletta. ...
Posted by Michael Wonder on 05 Feb 2018
AMAG Pharmaceuticals announces FDA approval of supplemental new drug application for Feraheme (ferumoxytol injection)
5 February 2018 - Feraheme is now a treatment option for all eligible adult patients with iron deficiency anaemia. ...
Posted by Michael Wonder on 22 Dec 2017
FDA approves drug to treat dangerously low blood pressure
21 December 2017 - The U.S. FDA today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in ...
Posted by Michael Wonder on 22 Sep 2017
Market approval for drugs in the EU: time to change direction?
22 September 2017 - Since 1995, the EMA has been the EU authority responsible for assessing the efficacy, safety and ...
Posted by Michael Wonder on 03 Sep 2017
European Commission approves expanded use of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism in children with end-stage renal disease on dialysis
31 August 2017 - Amgen today announced that the European Commission has granted marketing authorisation of a paediatric formulation (granules in ...
Posted by Michael Wonder on 01 Aug 2017
Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma
1 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US ...
Posted by Michael Wonder on 29 Jul 2017
European Commission grants AbbVie's Maviret (glecaprevir/pibrentasvir) marketing authorisation for the treatment of chronic hepatitis C in all major genotypes (GT1-6)
28 July 2017 - AbbVie's investigational, pan-genotypic HCV treatment is also under priority review by the U.S. FDA. ...
Posted by Michael Wonder on 26 Jul 2017
Health Canada approves Adcetris (brentuximab vedotin) for the post-ASCT consolidation treatment of patients with Hodgkin lymphoma at increased risk of relapse or progression
25 July 2017 - Approval based on positive phase 3 AETHERA clinical trial results. ...
Posted by Michael Wonder on 22 Jul 2017
AbbVie receives CHMP positive opinion for Humira (adalimumab) for the treatment of paediatric patients with chronic non-infectious anterior uveitis
21 July 2017 - The CHMP opinion is based on results from SYCAMORE, an investigator-initiated clinical trial. ...