Blog
RSS FeedPosted by Michael Wonder on 27 May 2020
Bristol Myers Squibb receives European Commission approval for Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease
27 May 2020 - Zeposia is the only approved sphingosine-1-phosphate receptor modulator for RRMS patients with active disease. ...
Posted by Michael Wonder on 27 May 2020
EMA publishes agenda for 25-28 May 2020 CHMP meeting
27 May 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 May 2020
EMA commissions independent research to prepare for real world monitoring of COVID-19 vaccines
27 May 2020 - EMA is engaging early with researchers to ensure that a European infrastructure will be in place to ...
Posted by Michael Wonder on 27 May 2020
U.S. FDA approves Opdivo (nivolumab) and Yervoy (ipilimumab) combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer
26 May 2020 - Approval marks sixth indication for Opdivo and Yervoy-based combinations across five types of cancer. ...
Posted by Michael Wonder on 27 May 2020
Cellectar receives FDA fast track designation for CLR 131 in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinaemia
26 May 2020 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in lymphoplasmacytic ...
Posted by Michael Wonder on 27 May 2020
Rockwell Medical files new drug submission with Health Canada for marketing approval of Triferic AVNU
26 May 2020 - Rockwell Medical today announced the filing of a new drug submission with Health Canada for Triferic AVNU ...
Posted by Michael Wonder on 27 May 2020
FDA approves first treatment for a form of bladder dysfunction in paediatric patients as young as 2 years of age
26 May 2020 - The U.S. FDA today granted approval to VESIcare LS (solifenacin succinate) oral suspension for the treatment of ...
Posted by Michael Wonder on 27 May 2020
FDA approves only drug in U.S. to treat severe malaria
26 May 2020 - Today, the U.S. FDA approved artesunate for injection to treat severe malaria in adult and paediatric patients. ...
Posted by Michael Wonder on 26 May 2020
FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
26 May 2020 - In the pivotal trial, more than twice as many children achieved clear or almost clear skin and ...
Posted by Michael Wonder on 26 May 2020
Aurinia completes submission of new drug application to the U.S. FDA for voclosporin for the treatment of lupus nephritis
26 May 2020 - Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the ...
Posted by Michael Wonder on 26 May 2020
Kala Pharmaceuticals announces FDA acceptance of new drug application for Eysuvis for dry eye disease
26 May 2020 - FDA sets PDUFA goal date of 30 October 2020. ...
Posted by Michael Wonder on 26 May 2020
Protara Therapeutics receives fast track designation from U.S. FDA for intravenous choline chloride for the treatment of intestinal failure associated liver disease
26 May 2020 - Protara Therapeutics today announced that the U.S. FDA has granted fast track designation to intravenous choline chloride ...
Posted by Michael Wonder on 26 May 2020
EMA calls for high-quality observational research in context of COVID-19
26 May 2020 - For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, ...
Posted by Michael Wonder on 26 May 2020
Australians stick with malaria drug hydroxychoroquine trial
26 May 2020 - Australian researchers are pressing ahead with administering the controversial antimalarial drug hydroxychloroquine in at least one ...
Posted by Michael Wonder on 26 May 2020
Ofev (nintedanib) now available in Canada for adults living with progressive fibrosing interstitial lung diseases
25 May 2020 - Ofev slowed lung function decline in PF-ILD patients by 57% compared to placebo. ...