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RSS FeedPosted by Michael Wonder on 07 Oct 2020
Oncternal Therapeutics receives rare paediatric disease designation from U.S. FDA for TK216 for treatment of Ewing sarcoma
6 October 2020 - Oncternal Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TK216, an ...
Posted by Michael Wonder on 07 Oct 2020
Aegle Therapeutics receives rare paediatric disease designation from the FDA for AGLE-102 for patients with dystrophic epidermolysis bullosa
6 October 2020 - -- Aegle Therapeutics today announced that the FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 06 Oct 2020
Y-mAbs provides regulatory update on omburtamab for the treatment of patients with neuroblastoma
5 October 2020 - Y-mAbs Therapeutics today announced that Y-mAbs has received a Refusal to File letter from the U.S. FDA ...
Posted by Michael Wonder on 06 Oct 2020
FDA discloses vaccine guidelines blocked by White House
7 October 2020 - The FDA has laid out its safety standards for developers of COVID-19 vaccines after the White House ...
Posted by Michael Wonder on 06 Oct 2020
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology
1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...
Posted 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 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
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
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
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 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 ...