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RSS FeedPosted by Michael Wonder on 15 Nov 2025
FDA’s new plausible mechanism pathway
12 November 2025 - Personalised therapies hold tremendous promise but challenge traditional models of drug and biologic development. ...
Posted by Michael Wonder on 15 Nov 2025
Sarepta announces FDA’s approval of updated Elevidys Prescribing Information
14 November 2025 - Sarepta Therapeutics today announced an update to the prescribing information for Elevidys (delandistrogene moxeparvovec-rokl), the only ...
Posted by Michael Wonder on 14 Nov 2025
Outlook Therapeutics announces acceptance of biologics license application by FDA for ONS-5010 as a treatment for wet AMD
13 November 2025 - Outlook Therapeutics today announced that the US FDA has acknowledged receipt of the resubmission of the ...
Posted by Michael Wonder on 14 Nov 2025
ITM announces FDA acceptance of new drug application and PDUFA date for lutetium Lu 177 edotreotide (ITM-11) in gastro-enteropancreatic neuroendocrine tumours
13 November 2025 - 2025 - ITM Isotope Technologies today announced that the US FDA completed its filing review and accepted ...
Posted by Michael Wonder on 14 Nov 2025
Allterum Therapeutics receives FDA fast track designation for 4A10 in acute lymphoblastic leukaemia
11 November 2025 - Allterum Therapeutics today announced that the US FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves Promega OncoMate MSI Dx analysis system as companion diagnostic for Keytruda in combination with Lenvima in advanced endometrial carcinoma
11 November 2025 - The US FDA has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves new interchangeable biosimilar to Perjeta
13 November 2025 - Today, the FDA approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as an interchangeable biosimilar to Perjeta (pertuzumab, ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves ziftomenib for relapsed or refractory acute myeloid leukaemia with a NPM1 mutation
13 November 2025 - Today, the FDA approved ziftomenib (Komzifti, Kura Oncology), a menin inhibitor, for adults with relapsed or ...
Posted by Michael Wonder on 12 Nov 2025
Parabilis Medicines receives FDA fast track designation for FOG-001, the first and only direct inhibitor of the β-catenin:TCF interaction for the treatment of desmoid tumours
12 November 2025 - Parabilis Medicines today announced that the US FDA has granted fast track product designation to FOG-001 ...
Posted by Michael Wonder on 12 Nov 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 12 Nov 2025
March Biosciences receives FDA regenerative medicine advanced therapy designation for MB-105 in relapsed/refractory CD5 positive T-cell lymphoma
11 March 2025 - March Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 09 Nov 2025
Mark Cuban Cost Plus Drug Company expands access with addition of Starjemza (ustekinumab-hmny) to give patients more power over prescription costs
6 November 2025 - New biosimilar added to portfolio reinforces the company's commitment to transparency and access ...
Posted by Michael Wonder on 08 Nov 2025
FDA awards second batch of national priority vouchers
6 November 2025 - The US FDA today announced six additional awardees under the Commissioner’s National Priority Voucher pilot program. ...
Posted by Michael Wonder on 08 Nov 2025
Vera Therapeutics submits biologics license application to US FDA through accelerated approval program for atacicept for the treatment of adults with IgA nephropathy
7 November 2025 - Vera Therapeutics today announced it has submitted a biologics license application to the US FDA through ...