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RSS FeedPosted by Michael Wonder on 08 Oct 2020
Y-mAbs’ nivatrotamab for the treatment of patients with neuroblastoma granted orphan drug designation and rare paediatric disease designation by FDA
7 October 2020 - Y-mAbs Therapeutics today announced that the FDA has granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 08 Oct 2020
NDA submission for Polarean’s hyperpolarised 129 Xenon gas drug-device diagnostic for lung imaging
7 October 2020 - Polarean Imaging announces its submission of a new drug application and request for priority review to the ...
Posted by Michael Wonder on 08 Oct 2020
To maintain trust and respectability, digital health companies must commit to the highest standards
7 October 2020 - The digital health gold rush is on. Teledoc’s $18.5 billion acquisition of Livongo reflects the valuation ...
Posted by Michael Wonder on 07 Oct 2020
Eli Lilly asks FDA to authorise COVID-19 antibody drug
7 October 2020 - Company says it could supply one million doses of the treatment this year, if regulator authorises emergency ...
Posted by Michael Wonder on 07 Oct 2020
FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
Posted by Michael Wonder on 07 Oct 2020
Eton Pharmaceuticals submits new drug application to the FDA for topiramate oral solution
6 October 2020 - Application submitted for the treatment of partial-onset seizures and migraine. ...
Posted 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 ...