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RSS FeedPosted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
Posted by Michael Wonder on 12 Nov 2020
Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away
11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...
Posted by Michael Wonder on 10 Nov 2020
Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis
10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...
Posted by Michael Wonder on 22 Oct 2020
Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment
22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...
Posted by Michael Wonder on 19 Oct 2020
Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD
19 October 2020 - Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...
Posted by Michael Wonder on 22 Sep 2020
Knight and TherapeuticsMD announce Health Canada approval of Bijuva
21 September 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...
Posted by Michael Wonder on 01 Sep 2020
FDA accepts Vertex’s supplemental new drug applications for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for additional CFTR mutations
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...
Posted by Michael Wonder on 24 Aug 2020
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis in people ages 12 years and older
21 August 2020 - For the first time, up to 10,000 people in Europe ages 12 years and older with one ...
Posted by Michael Wonder on 07 Aug 2020
ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1
August 2020 - ViiV Healthcare today announced that the US FDA approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment ...
Posted by Michael Wonder on 25 Jul 2020
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of ...
Posted by Michael Wonder on 23 Jul 2020
MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora (calcipotriene 0.005% and betamethasone dipropionate 0.064% cream) for adults with plaque psoriasis
22 July 2020 - MC2 Therapeutics announced today that the U.S. FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w ...
Posted by Michael Wonder on 17 Jul 2020
MC2 Therapeutics announces submission of marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))
16 July 2020 - MC2 Therapeutics today announced the submission of its marketing authorisation application in EU for Wynzora cream (50 ...
Posted by Michael Wonder on 07 Jul 2020
FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes
7 July 2020 - Today, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (Inqovi, Astex ...