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RSS FeedPosted by Michael Wonder on 06 Oct 2020
FDA announces all time low rates for FY2021 priority review vouchers
5 October 2020 - The US FDA has announced historic low rates for the fiscal year 2021 fees to use ...
Posted by Michael Wonder on 06 Oct 2020
FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease
5 October 2020 - GlycoMimetics today announced that the U.S. FDA has granted the Company a rare paediatric disease designation for ...
Posted by Michael Wonder on 06 Oct 2020
PixCell Medical announces regulatory approval from Australian TGA for HemoScreen point of care hematology analyser
5 October 2020 - PixCell Medical announced today that it has received regulatory approval from the Australian TGA for the ...
Posted by Michael Wonder on 05 Oct 2020
Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November
5 October 2020 - Company will seek emergency use authorisation for experimental vaccine. ...
Posted by Michael Wonder on 05 Oct 2020
ImmunoGen announces FDA breakthrough therapy designation for IMGN632 in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm
5 October 2020 - ImmunoGen today announced that the U.S. FDA has granted breakthrough therapy designation for IMGN632 for the ...
Posted by Michael Wonder on 05 Oct 2020
EU regulator starts safety review of coronavirus drug
3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...
Posted by Michael Wonder on 05 Oct 2020
CDER proposes withdrawal of approval for Makena
5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) ...
Posted by Michael Wonder on 05 Oct 2020
Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product
5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...
Posted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...
Posted by Michael Wonder on 05 Oct 2020
Chembio Diagnostics receives FDA approval for DPP HIV-syphilis system
2 October 2020 - Chembio Diagnostics today announced that the U.S. FDA has approved the premarket approval application for the DPP ...
Posted by Michael Wonder on 04 Oct 2020
bluebird bio announces European Medicines Agency’s acceptance of marketing authorisation application for elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy for cerebral adrenoleukodystrophy
2 October 2020 - European Medicines Agency will evaluate eli-cel application under accelerated assessment. ...
Posted by Michael Wonder on 04 Oct 2020
BioMarin receives FDA fast track designation for investigational gene therapy, BMN 307
2 October 2020 - Second investigational gene therapy in clinic, potential third therapy in PKU franchise. ...
Posted by Michael Wonder on 04 Oct 2020
Kyowa Kirin announces European Commission approval of Crysvita (burosumab) for the treatment of X-linked hypophosphataemia in older adolescents and adults
2 October 2020 - More people in Europe are now eligible for treatment with Crysvita, the only therapy that targets the ...
Posted by Michael Wonder on 02 Oct 2020
FDA approves drug combination for treating mesothelioma
2 October 2020 - First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibres. ...
Posted by Michael Wonder on 02 Oct 2020
Biotech industry pushes Trump Administration to release new vaccine guidelines
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...