Blog
RSS FeedPosted 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 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
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 17 May 2025
PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025
16 May 2025 - PharmaTher today announced the US FDA has extended the approval goal date for the review of ...
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
Kaerus Bioscience's lead candidate KER-0193 granted orphan drug designation and rare paediatric drug designation by US FDA for treatment of Fragile X syndrome
14 May 2025 - Kaerus Bioscience today announces that its lead candidate KER-0193 has been granted both orphan drug designation and ...
Posted by Michael Wonder on 16 May 2025
FDA grants regenerative medicine advanced therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
15 May 2025 - BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to ...
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 15 May 2025
FDA sets PDUFA date for Xspray Pharma’s re-submitted application for Dasynoc
14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc. ...
Posted by Michael Wonder on 15 May 2025
FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...
Posted by Michael Wonder on 15 May 2025
BioCryst announces FDA acceptance of NDA for Orladeyo (berotralstat) oral granules in patients with hereditary angioedema aged 2 to 11 years
14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025. ...
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 14 May 2025
FDA fast tracks therapy for radiation-induced dry mouth
7 May 2025 - A therapy under development at the University of Wisconsin School of Medicine and Public Health to ...
Posted by Michael Wonder on 13 May 2025
RegenxBio announces FDA acceptance and priority review of the BLA for RGX-121 for MPS II
13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025. ...