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RSS FeedPosted by Michael Wonder on 01 Oct 2025
Sentynl Therapeutics updates on its NDA for CUTX-101
1 October 2025 - Sentynl Therapeutics announced today that the US FDA has issued a complete response letter relating to ...
Posted by Michael Wonder on 01 Oct 2025
Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease
1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...
Posted by Michael Wonder on 01 Oct 2025
Disc Medicine announces submission of new drug application to US FDA for accelerated approval of bitopertin for patients with erythropoietic protoporphyria
30 September 2025 - Disc is seeking accelerated approval and priority review of its new drug application submission. ...
Posted by Michael Wonder on 01 Oct 2025
Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once weekly basal insulin treatment for adults with type 2 diabetes
29 September 2025 - Awiqli (insulin icodec) injection, if approved, has the potential to be the first once weekly basal insulin ...
Posted by Michael Wonder on 30 Sep 2025
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from methamphetamine
30 September 2025 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 30 Sep 2025
AbbVie submits biologics license application to US FDA for pivekimab sunirine - an investigational antibody-drug conjugate to treat rare cancer with limited treatment options
30 September 2025 - Biologics license application based on data from the global Phase 1/2 CADENZA trial. ...
Posted by Michael Wonder on 30 Sep 2025
Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria
30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology ...
Posted by Michael Wonder on 30 Sep 2025
Novo Nordisk submits biologics license application to FDA for Mim8; an investigational, prophylaxis treatment for people living with haemophilia A with or without inhibitors
29 September 2025 - In haemophilia A, denecimig is designed to help the body form blood clots more effectively and was ...
Posted by Michael Wonder on 30 Sep 2025
US FDA approves Tremfya (guselkumab) for the treatment of paediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
29 September 2025 - Approval was based on PROTOSTAR study, which showed paediatric patients receiving Tremfya achieved high levels of ...
Posted by Michael Wonder on 26 Sep 2025
Crinetics announces FDA approval of Palsonify (paltusotine) for the treatment of adults with acromegaly
25 September 2025 - Approval based on data from two pivotal Phase 3 trials where Palsonify was well tolerated and resulted ...
Posted by Michael Wonder on 26 Sep 2025
AbbVie submits new drug application to US FDA for tavapadon for the treatment of Parkinson's fisease
26 September 2025 - Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's ...
Posted by Michael Wonder on 26 Sep 2025
Evkeeza (evinacumab-dgnb) ANGPTL3 antibody approved in the US for children as young as 1 year old with ultra-rare form of high cholesterol
26 September 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct ...
Posted by Michael Wonder on 26 Sep 2025
Vertex announces key advancements across kidney portfolio
25 September 2025 - Vertex announced today that the FDA has granted breakthrough therapy designation to povetacicept for the treatment of ...
Posted by Michael Wonder on 25 Sep 2025
FDA approves imlunestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
25 September 2025 - Today, the FDA approved imlunestrant (Inluriyo, Eli Lilly), an oestrogen receptor antagonist, for adults with oestrogen ...