Blog
RSS FeedPosted by Michael Wonder on 22 May 2025
Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease
22 May 2025 - Approval based on the positive MATINEE and METREX Phase 3 trials. ...
Posted by Michael Wonder on 21 May 2025
US FDA grants approval for Jivi anti-hemophilic factor (recombinant), PEGylated-aucl in paediatric patients 7 to under 12 years of age with haemophilia A
19 May 2025 - Bayer announced that the US FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII ...
Posted by Michael Wonder on 20 May 2025
US FDA approves BLA for Novavax's COVID-19 vaccine
19 May 2025 - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the US. ...
Posted by Michael Wonder on 18 May 2025
FDA clears first blood test used in diagnosing Alzheimer’s disease
16 May 2025 - New test provides less invasive option, reduces reliance on PET scans and increases diagnosis accessibility. ...
Posted by Michael Wonder on 16 May 2025
Amneal receives US FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults
15 May 2025 - Product will be available for appropriate patients in the second half of 2025 ...
Posted by Michael Wonder on 16 May 2025
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...
Posted by Michael Wonder on 14 May 2025
FDA grants accelerated approval to telisotuzumab vedotin-tllv for non-small cell lung cancer with high c-Met protein overexpression
14 May 2025 - Today, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met-directed antibody and microtubule ...
Posted by Michael Wonder on 14 May 2025
FDA approves belzutifan for pheochromocytoma or paraganglioma
14 May 2025 - Today, the FDA approved belzutifan (Welireg, Merck) for adult and paediatric patients 12 years and older ...
Posted 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 ...