Blog
RSS FeedPosted by Michael Wonder on 19 Nov 2025
FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
19 November 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) for adults with neurofibromatosis type 1 who have ...
Posted by Michael Wonder on 19 Nov 2025
Grifols receives expanded indication for Thrombate III (antithrombin III [human]) label in US, strengthening treatment options for pediatric patients
18 November 2025 - FDA approval was based on submitted data extrapolation from two clinical trials in adult patients addressing critical ...
Posted by Michael Wonder on 18 Nov 2025
Arrowhead Pharmaceuticals announces FDA approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
18 November 2025 - The FDA approval is based on positive results from the Phase 3 PALISADE study where Redemplo significantly ...
Posted by Michael Wonder on 18 Nov 2025
FDA approves epcoritamab-bysp for follicular lymphoma indications
18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) with lenalidomide and rituximab for relapsed or refractory follicular ...
Posted 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 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
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 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 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 06 Nov 2025
FDA approval of Caplyta (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
6 November 2025 - Johnson & Johnson announced today that the US FDA approved Caplyta (lumateperone) as an adjunctive therapy with ...
Posted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...