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RSS FeedPosted 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
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 12 Jul 2023
Better Therapeutics receives FDA authorisation for AspyreRx to treat adults with type 2 diabetes
10 July 2023 - In a randomised controlled trial AspyreRx demonstrated clinically meaningful and statistically significant durable reductions in A1c. ...
Posted by Michael Wonder on 10 Jul 2023
US FDA approves expanded indication for Novartis Leqvio (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease
10 July 2023 - Expanded indication now enables broader use of Leqvio for LDL-C reduction in patients with primary hyperlipidaemia (high ...
Posted by Michael Wonder on 06 Jul 2023
FDA converts novel Alzheimer’s disease treatment to traditional approval
6 July 2023 - Action follows confirmatory trial to verify clinical benefit. ...
Posted by Michael Wonder on 04 Jul 2023
Amneal launches authorised generic for Xyrem (sodium oxybate) and receives FDA approval for five complex generics in the second quarter
3 July 2023 - Launches authorized generic for Xyrem (sodium oxybate) in the US, representing another new complex generic product launch. ...
Posted by Michael Wonder on 03 Jul 2023
Nevakar Injectables announces FDA approval of cyclophosphamide RTD solution
3 July 2023 - Ready to dilute, multi-dose vials reduce compounding time and waste. ...
Posted by Michael Wonder on 03 Jul 2023
Amneal receives US FDA complete response letter for IPX203
3 July 2023 - Letter requests additional pharmacokinetic data. ...
Posted by Michael Wonder on 03 Jul 2023
Roche receives FDA clearance for additional Alzheimer's disease cerebrospinal fluid assays, supporting timely diagnosis and treatment decision-making
27 June 2023 - The Elecsys tTau/Abeta42 ratio helps clinicians define Alzheimer's disease biologically and expands Roche's Alzheimer's CSF portfolio to ...
Posted by Michael Wonder on 03 Jul 2023
Genentech withdraws use of Gavreto in US for a type of thyroid cancer, says partner Blueprint
30 June 2023 - Genentech will withdraw Gavreto from use in the US for treating a type of thyroid cancer ...
Posted by Michael Wonder on 30 Jun 2023
FDA approves ARUP Laboratories' AAV5 DetectCDx, a first-ever companion diagnostic immunoassay for a gene therapy
29 June 2023 - FDA issues simultaneous approval of Roctavian (valoctocogene roxaparvovec-rvox), BioMarin's gene therapy for severe haemophilia A. ...
Posted by Michael Wonder on 29 Jun 2023
US FDA approves BioMarin's Roctavian (valoctocogene roxaparvovec-rvox), the first and only gene therapy for adults with severe haemophilia A
29 June 2023 - Roctavian's approval was based on durability, efficacy and safety results from the largest and longest Phase 3 ...
Posted by Michael Wonder on 29 Jun 2023
FDA approves first cellular therapy to treat patients with type 1 diabetes
28 June 2023 - Today, the US FDA approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased ...
Posted by Michael Wonder on 29 Jun 2023
Eton Pharmaceuticals receives complete response letter for dehydrated alcohol injection
28 June 2023 - Eton Pharmaceuticals announced today that the US FDA issued a complete response letter in response to its ...