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RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Oct 2020
Genetron Health receives U.S. FDA breakthrough device designation for its blood based NGS test for early detection of hepatocellular carcinoma
30 September 2020 - Genetron Holdings today announced that its blood-based next-generation sequencing test, HCCscreen, has been granted breakthrough device designation ...
Posted by Michael Wonder on 01 Oct 2020
Kadmon announces submission of new drug application to the U.S. FDA for belumosudil in patients with chronic graft versus host disease
30 September 2020 - Application being reviewed under FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 01 Oct 2020
US FDA grants rare paediatric disease designation to ATL1102 for the treatment of DMD
30 September 2020 - Priority review voucher may be utilised to expedite marketing authorisation review by FDA. ...
Posted by Michael Wonder on 01 Oct 2020
US to widen inquiry into AstraZeneca COVID vaccine destined for Australia
1 October 2020 - The US Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca's ...
Posted by Michael Wonder on 30 Sep 2020
The FDA and the importance of trust
30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what ...
Posted by Michael Wonder on 30 Sep 2020
Janssen submits new drug application to U.S. FDA for Uptravi (selexipag) injection for intravenous use to treat pulmonary arterial hypertension
30 September 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA for Uptravi ...
Posted by Michael Wonder on 30 Sep 2020
Simponi Aria (golimumab) approved by the U.S. FDA for active polyarticular juvenile idiopathic arthritis and extension of its active psoriatic arthritis indication in patients 2 years of age and older
30 September 2020 - Phase 3 GO-VIVA clinical trial adds to the growing body of evidence for Simponi Aria. ...
Posted by Michael Wonder on 30 Sep 2020
Study identifies shortcomings in FDA evaluations for new opioid drug approvals over two decades
29 September 2020 - Systematic assessment of safety-related outcomes has been lacking, researchers find. ...
Posted by Michael Wonder on 29 Sep 2020
Infinity receives fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced triple negative breast cancer
29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) ...