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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Oct 2020
Provention Bio files clinical module for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
30 September 2020 - Expect to complete filing of the rolling biologics license application for teplizumab in Q4 2020. ...
Posted by Michael Wonder on 02 Oct 2020
Development of COVID-19 vaccine won’t be affected by politics, Pfizer CEO says
1 October 2020 - Albert Bourla sent an all-hands letter saying company won’t bow to political pressure. ...
Posted by Michael Wonder on 02 Oct 2020
Farxiga granted breakthrough therapy designation in US for chronic kidney disease
2 October 2020 - Designation follows DAPA-CKD Phase 3 trial results in which Farxiga demonstrated unprecedented reduction in the risk of ...
Posted by Michael Wonder on 02 Oct 2020
HHS says Gilead, distributor can directly sell COVID-19 drug in U.S.
1 October 2020 - The U.S. Department of Health and Human Services said on Thursday that U.S. hospitals can now ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019
1 October 2020 - Phase 1 clinical trial is now enrolling patients with blood cancers. ...
Posted by Michael Wonder on 02 Oct 2020
Mesoblast receives complete response letter from the FDA for biologics license application for steroid-refractory acute graft versus host disease in children
2 October 2020 - Mesoblast announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter ...
Posted by Michael Wonder on 02 Oct 2020
Lantheus submits new drug application to the U.S. FDA for PyL (18F DCFPyL), a PSMA targeted prostate cancer imaging agent
30 September 2020 - Sep. 30, 2020-- Lantheus today announced the submission of a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 02 Oct 2020
Pfizer receives FDA fast track designation for Duchenne muscular dystrophy investigational gene therapy
1 October 2020 - Pfizer today announced that its investigational gene therapy candidate (PF-06939926) being developed to treat Duchenne muscular dystrophy ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track status to Aegle Therapeutics' AGLE-102 for the treatment of dystrophic epidermolysis bullosa
1 October 2020 - Aegle Therapeutics Corporation today announced the U.S. FDA has granted fast track designation to AGLE-102 for ...