MAESTrO: Blog

Posted by Michael Wonder on 25 Apr 2025

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

23 April 2025 - Today, the FDA approved penpulimab-kcqx (Akeso Biopharma) with cisplatin or carboplatin and gemcitabine for the first-line ...

Read more →

Posted by Michael Wonder on 18 Apr 2025

Regeneron provides update on Eylea HD (aflibercept) injection 8 mg supplemental biologics license application

18 April 2025 - Regeneron Pharmaceuticalstoday announced that the US FDA has issued a complete response letter regarding the supplemental biologics ...

Read more →

Posted by Michael Wonder on 18 Apr 2025

Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

18 April 2025 - Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo. ...

Read more →

Posted by Michael Wonder on 17 Apr 2025

Eylea HD (aflibercept) injection 8 mg sBLA accepted for FDA priority review for both the treatment of macular oedema following retinal vein occlusion and for monthly dosing in approved indications

17 April 2025 - If approved, Eylea HD would be the first and only treatment for RVO indicated for up to ...

Read more →

Posted by Michael Wonder on 17 Apr 2025

Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5

16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...

Read more →

Posted by Michael Wonder on 16 Apr 2025

FDA grants fast track status to Prescient’s PTX-100, advancing commercialisation pathway

16 April 2025 - Prescient Therapeutics has received fast track designation from the US FDA for its lead candidate PTX-100, ...

Read more →

Posted by Michael Wonder on 16 Apr 2025

US FDA grants interchangeable designation to Yuflyma (adalimumab-aaty), Celltrion's biosimilar to Humira (adalimumab)

14 April 2025 - Interchangeable designation of Yuflyma is supported by positive data from the Phase 3 interchangeability study in ...

Read more →

Posted by Michael Wonder on 14 Apr 2025

SynOx Therapeutics receives fast track designation from US FDA for emactuzumab for tenosynovial giant cell tumours

14 April 2025 - SynOx Therapeutics today announced that the US FDA has granted fast track designation to emactuzumab for the ...

Read more →

Posted by Michael Wonder on 11 Apr 2025

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

11 April 2025 - Today, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, ...

Read more →

Posted by Michael Wonder on 11 Apr 2025

US FDA grants full approval of Vitrakvi (larotrectinib) for adult and paediatric patients with NTRK gene fusion-positive solid tumours

10 April 2025 - The full approval of Vitrakvi is based on the results of confirmatory trials that support Vitrakvi as ...

Read more →

Posted by Michael Wonder on 11 Apr 2025

argenx announces FDA approval of Vyvgart Hytrulo pre-filled syringe for self-injection in generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy

10 April 2025 - Self-injection provides generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy patients with flexibility for when and where to receive ...

Read more →