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RSS FeedPosted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted by Michael Wonder on 03 Jun 2020
The FDA should not rush a COVID-19 vaccine
2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic. ...
Posted by Michael Wonder on 03 Jun 2020
Clarity Pharmaceuticals announces that the US FDA grants rare paediatric disease designation to Copper Cu 67 sartate for the treatment of neuroblastoma
3 June 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 03 Jun 2020
Antimicrobial approvals are not bottlenecked by FDA
3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...
Posted by Michael Wonder on 03 Jun 2020
Law makers, government watchdog blast FDA for poor oversight of U.S. drug supply chain
2 June 2020 - A government watchdog blasted the FDA for fumbling its oversight of the safety of the U.S. ...
Posted by Michael Wonder on 03 Jun 2020
Hahn: FDA will make some changes amid COVID-19 permanent
1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...
Posted by Michael Wonder on 03 Jun 2020
Zoloft falls into shortage as virus anxiety strains supplies
2 June 2020 - Drug makers blame increase in demand and ingredient shortfall. ...
Posted by Michael Wonder on 03 Jun 2020
The CDC waited its entire existence for this moment. What went wrong?
3 June 2020 - Americans returning from China landed at U.S. airports by the thousands in early February, potential carriers ...
Posted by Michael Wonder on 03 Jun 2020
Helsinn Group announces FDA approval of a new liquid formulation of Akynzeo (fosnetupitant/palonosetron) injection in the United States
2 June 2020 - Helsinn today announces that the U.S. FDA has approved the ready-to-dilute liquid formulation of Akynzeo (fosnetupitant/palonosetron) ...
Posted by Michael Wonder on 02 Jun 2020
Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review
2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...
Posted by Michael Wonder on 02 Jun 2020
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...
Posted by Michael Wonder on 02 Jun 2020
Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 02 Jun 2020
AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma
1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...
Posted by Michael Wonder on 02 Jun 2020
FDA accepts Shionogi’s supplemental new drug application with priority review for Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 June 2020 - Shionogi today announced the U.S. FDA has accepted the company’s supplemental new drug application for Fetroja ...
Posted by Michael Wonder on 01 Jun 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis
1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...