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RSS FeedPosted by Michael Wonder on 08 May 2025
FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
8 May 2025 - Today, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, ...
Posted by Michael Wonder on 06 May 2025
Teva and Alvotech announce FDA approval of interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
5 May 2025 - The US FDA has approved Selarsdi (ustekinumab-aekn) as interchangeable with the reference biologic Stelara (ustekinumab) in all ...
Posted by Michael Wonder on 02 May 2025
Satsuma Pharmaceuticals announces US FDA approval for Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
Posted by Michael Wonder on 30 Apr 2025
Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
Posted by Michael Wonder on 30 Apr 2025
US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa
29 April 2025 - Rare paediatric disease priority review voucher granted by FDA. ...
Posted by Michael Wonder on 29 Apr 2025
Rinvoq (upadacitinib) receives US FDA approval for giant cell arteritis
29 April 2025 - Rinvoq (upadacitinib) is now the first and only oral Janus kinase inhibitor approved for the treatment of ...
Posted by Michael Wonder on 28 Apr 2025
Telix provides regulatory update on TLX101-CDx
28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
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 ...
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. ...
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. ...
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 ...
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 ...
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 ...
Posted by Michael Wonder on 11 Apr 2025
Biocon Biologics announces US FDA approval for Jobevne, biosimilar bevacizumab
10 April 2025 - Biocon Biologics today announced that the US FDA has approved Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for ...
Posted by Michael Wonder on 09 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...