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RSS FeedPosted by Michael Wonder on 07 Aug 2020
Unwavering regulatory safeguards for COVID-19 vaccines
7 August 2020 - The coronavirus disease 2019 (COVID-19) pandemic has disrupted normal life and had significant consequences for human health, ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves oral treatment for spinal muscular atrophy
7 August 2020 - The U.S. Food and Drug Administration today approved Evrysdi (risdiplam) to treat patients two months of age ...
Posted 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
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 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
ReViral announces FDA fast track designation granted to sisunatovir for the treatment of serious respiratory syncytial virus infection
4 August 2020 - ReViral today announced that the U.S. FDA has granted fast track designation to sisunatovir for the ...
Posted by Michael Wonder on 05 Aug 2020
Leo Pharma announces US FDA fast track designation for delgocitinib cream for the treatment of adults with moderate to severe chronic hand eczema
4 August 2020 - Leo Pharma today announced that delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted fast ...
Posted by Michael Wonder on 05 Aug 2020
Cerecor receives rare paediatric disease designation for CERC-006 in lymphatic malformations
4 August 2020 - Cerecor today announced that the U.S. FDA granted rare paediatric disease designation to CERC-006, a dual inhibitor ...