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RSS FeedPosted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...
Posted by Michael Wonder on 16 Nov 2025
Ascelia Pharma announces FDA acceptance of Orviglance new drug application for review
15 November 2025 - Ascelia Pharma today announced that the US FDA has accepted the new drug application for Orviglance for ...
Posted 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 ...