Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2023
How a drug maker profited by slow walking a promising HIV therapy
22 July 2023 - Gilead delayed a new version of a drug, allowing it to extend the patent life of a ...
Posted by Michael Wonder on 22 Jul 2023
Verrica Pharmaceuticals announces FDA approval of Ycanth (cantharidin) topical solution as the first FDA approved treatment of paediatric and adult patients with molluscum contagiosum
21 July 2023 - Ycanth is a drug-device combination product administered by a health care professional; Verrica plans to make Ycanth ...
Posted by Michael Wonder on 20 Jul 2023
FDA approves quizartinib for newly diagnosed acute myeloid leukaemia
20 July 2023 - Today, the FDA approved quizartinib (Vanflyta, Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine ...
Posted by Michael Wonder on 20 Jul 2023
Advent Therapeutics receives FDA rare paediatric disease designation for retinol palmitate for prevention of bronchopulmonary dysplasia in premature infants
20 July 2023 - Advent plans FDA PDUFA meeting late 2023 to establish pathway for US approval of lead injectable ...
Posted by Michael Wonder on 19 Jul 2023
FDA grants fast track designation for Ambrx’s ARX517 for the treatment of metastatic castration resistant prostate cancer
19 July 2023 - Ambrx Biopharma today announced that the US FDA has granted fast track designation to Ambrx’s proprietary anti-PSMA ...
Posted by Michael Wonder on 18 Jul 2023
Madrigal Pharmaceuticals completes submission of new drug application seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
17 July 2023 - Madrigal Pharmaceuticals announced the completion of the rolling submission of its new drug application to the US ...
Posted by Michael Wonder on 17 Jul 2023
Karyopharm receives FDA fast track designation for selinexor for the treatment of myelofibrosis
17 July 2023 - Regulatory designation includes primary myelofibrosis, post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis. ...
Posted by Michael Wonder on 17 Jul 2023
FDA approves new drug to prevent RSV in babies and toddlers
17 July 2023 - Today, the US FDA approved Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus lower respiratory tract ...
Posted by Michael Wonder on 17 Jul 2023
FDA starts review of HLB's HCC drug rivoceranib
17 July 2023 - HLB said the US FDA has initiated a review for approving a combination therapy of rivoceranib ...
Posted by Michael Wonder on 14 Jul 2023
FDA approves Veklury (remdesivir) for COVID-19 treatment in patients with severe renal impairment, including those on dialysis
14 July 2023 - Veklury is now the first approved anti-viral treatment for patients across all stages of renal disease. ...
Posted by Michael Wonder on 14 Jul 2023
TheracosBio announces commercial availability of Brenzavvy (bexagliflozin) for the treatment of adults with type 2 diabetes
13 July 2023 - Distribution through Mark Cuban Cost Plus Drug Company introduces affordably priced SGLT2 inhibitors. ...
Posted by Michael Wonder on 14 Jul 2023
FDA issues complete response letter for PDP-716 NDA due to inspection findings at third-party API manufacturing facility
13 July 2023 - No issues with clinical efficacy or safety were identified in the complete response letter. ...
Posted by Michael Wonder on 13 Jul 2023
FDA approves first non-prescription daily oral contraceptive
13 July 2023 - Today, the US FDA approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily ...
Posted by Michael Wonder on 13 Jul 2023
Aridis’ AR-301 monoclonal antibody is among the first biologics to receive FDA’s qualified infectious diseases product designation
12 July 2023 - QIDP designation for biologics provides FDA priority review status. ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...