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RSS FeedPosted by Michael Wonder on 07 Aug 2020
Y-mAbs announces completion of submission of omburtamab biologics license application to FDA
6 August 2020 - Y-mAbs Therapeutics today announced that on 5 August 2020, the Company completed the submission of its biologics ...
Posted by Michael Wonder on 07 Aug 2020
US FDA grants rare paediatric disease designation to paxalisib for DIPG
7 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 07 Aug 2020
Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) receives marketing approval in Canada for patients with LEMS
6 August 2020 - Catalyst Pharmaceuticals today announced that Canada’s national health care regulatory agency, Health Canada, has approved the ...
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 06 Aug 2020
The world is spending nowhere near enough on a coronavirus vaccine
6 August 2020 - Far better to spend far too much. ...
Posted by Michael Wonder on 06 Aug 2020
Health experts to FDA: make your vaccine deliberations public
5 August 2020 - A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel ...
Posted by Michael Wonder on 06 Aug 2020
FDA approves GSK’s Blenrep (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma
6 August 2020 - Blenrep is the fifth major medicine approval for GSK in 2020. ...
Posted by Michael Wonder on 06 Aug 2020
Cimzia is the first and only biologic approved in Europe with the option for a reduced maintenance dose for patients across the full axial spondyloarthritis spectrum
5 August 2020 - European label extended to include a dose reduction option for the treatment of adult patients with axial ...
Posted by Michael Wonder on 05 Aug 2020
Anavex Life Sciences receives TGA Special Access Scheme approval for Anavex 2-73 (blarcamesine) for Alzheimer’s disease patients
5 August 2020 - Compassionate use Special Access Scheme approval for Alzheimer’s patients to continue treatment with Anavex 2-73 (blarcamesine) after ...
Posted by Michael Wonder on 05 Aug 2020
Canada inks deals with Pfizer, Moderna for coronavirus vaccine candidates
5 August 2020 - The Canadian government has signed new deals with pharmaceutical firms Pfizer and Moderna to secure millions ...
Posted by Michael Wonder on 05 Aug 2020
Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
5 August 2020 - FDA granted de novo class II for cobas EBV test following the agency’s breakthrough device designation. ...
Posted by Michael Wonder on 05 Aug 2020
Moderna is pricing coronavirus vaccine at $32 to $37 per dose for some customers
5 August 2020 - The company defines a small order of its vaccine as “in the millions.” ...
Posted by Michael Wonder on 05 Aug 2020
Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion
5 August 2020 - The doses will be provided to Americans at no cost if they’re used in a COVID-19 vaccination ...
Posted by Michael Wonder on 05 Aug 2020
Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-12 for the treatment of narcolepsy
5 August 2020 - FDA Orphan Drug Designation previously granted to Axsome for AXS-12 in narcolepsy. ...
Posted by Michael Wonder on 05 Aug 2020
MYR Pharmaceuticals receives conditional marketing authorisation by the European Commission for Hepcludex
4 August 2020 - MYR Pharmaceuticals is pleased to announce that the European Commission has granted the Conditional marketing authorisation ...