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RSS FeedPosted by Michael Wonder on 23 Jan 2023
Cadrenal Therapeutics granted FDA fast track designation for tecarfarin for prevention of systemic thromboembolism of cardiac origin in patients with end stage renal disease and atrial fibrillation
23 January 2023 - Cadrenal Therapeutics announced today that the US FDA has granted a fast track designation to tecarfarin ...
Posted by Michael Wonder on 23 Jan 2023
TheracosBio announces FDA approval of Brenzavvy (bexagliflozin) for the treatment of adults with type 2 diabetes
23 January 2023 - Once daily, oral SGLT2 inhibitor shown to reduce blood sugar and improve glycemic control as an adjunct ...
Posted by Michael Wonder on 23 Jan 2023
Blueprint Medicines announces FDA acceptance of supplemental new drug application for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
23 January 2023 - FDA grants priority review and sets PDUFA action date of 22 May 2023. ...
Posted by Michael Wonder on 22 Jan 2023
DualityBio announces DB-1303 granted fast track designation by the US FDA for the treatment of advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression
20 January 2023 - Duality Biologics announced that the US FDA has granted fast track designation to DB-1303 for the treatment ...
Posted by Michael Wonder on 21 Jan 2023
Stop blaming Biogen for putting profit at the expense of patients. Blame the systems that enabled it.
17 January 2023 - Two congressional committees recently released damning results of an 18 month investigation into the FDA’s approval of ...
Posted by Michael Wonder on 21 Jan 2023
MedPacto receives US FDA fast track designation for vactosertib for the treatment of metastatic osteosarcoma
17 January 2023 - MedPacto announced that the US FDA has granted fast track designation to vactosertib as a monotherapy ...
Posted by Michael Wonder on 20 Jan 2023
US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
20 January 2023 - The supplemental new drug application is based on results from the landmark EMPA-KIDNEY Phase 3 trial, which ...
Posted by Michael Wonder on 20 Jan 2023
Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose
19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...
Posted by Michael Wonder on 20 Jan 2023
FDA approves zanubrutinib for chronic lymphocytic leukaemia or small lymphocytic lymphoma
19 January 2023 - Today the FDA approved zanubrutinib (Brukinsa, BeiGene) for chronic lymphocytic leukaemia or small lymphocytic lymphoma. ...
Posted by Michael Wonder on 20 Jan 2023
US FDA issues complete response letter for accelerated approval of donanemab
19 January 2023 - Complete response letter based on limited number of patients with 12 month drug exposure data in the ...
Posted by Michael Wonder on 19 Jan 2023
Seagen announces FDA accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for people with previously treated RAS wild type, HER2 positive metastatic colorectal cancer
19 January 2023 - First FDA approved treatment in HER2 positive metastatic colorectal cancer. ...
Posted by Michael Wonder on 19 Jan 2023
Multiple sclerosis patients in US left without essential patient support program will now receive equivalent backing from Cycle Pharmaceuticals following FDA’s approval of Tascenso ODT (fingolimod)
17 January 2023 - Tascenso ODT is now approved by the US FDA as a bioequivalent to Gilenya (fingolimod hydrochloride), for ...
Posted by Michael Wonder on 19 Jan 2023
Evaxion receives FDA fast track designation for personalised cancer immunotherapy
19 January 2023 - Evaxion Biotech today announced that the US FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 19 Jan 2023
Synlogic receives rare paediatric disease designation from FDA for SYNB1934 for phenylketonuria
19 January 2023 - Synlogic today announced that SYNB1934 was granted rare paediatric disease designation by the US FDA for the ...
Posted by Michael Wonder on 19 Jan 2023
FDA accepts Intercept’s new drug application for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH
19 January 2023 - PDUFA target action date set for 22 June 2023. ...