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RSS FeedPosted 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 ...
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 ...
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, ...
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, ...
Posted by Michael Wonder on 09 Apr 2025
Outlook Therapeutics announces acceptance of biologics license application by US FDA for ONS-5010 as a treatment for wet AMD
8 April 2025 - PDUFA goal date of 27 August 2025. ...
Posted by Michael Wonder on 09 Apr 2025
Xspray Pharma re-submits its FDA application
8 April 2024 - Xspray Pharma has re-submitted its application for market approval for Dasynoc, the company's lead product candidate, an ...
Posted by Michael Wonder on 09 Apr 2025
Tenpoint Therapeutics submits new drug application to US FDA for Brimichol PF for the treatment of presbyopia
8 April 2025 - NDA submission includes efficacy and safety data for the first fixed-dose combination therapy from the world’s ...
Posted by Michael Wonder on 08 Apr 2025
Kura Oncology and Kyowa Kirin announce submission of new drug application for ziftomenib to FDA
8 April 2025 - Submission seeks approval for the treatment of adult patients with relapsed or refractory AML with a ...
Posted by Michael Wonder on 08 Apr 2025
Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention
7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for ...
Posted by Michael Wonder on 06 Apr 2025
Update on US FDA BLA for Novavax’s COVID-19 vaccine
2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date ...
Posted by Michael Wonder on 04 Apr 2025
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
3 April 2025 - Pending positive results and discussions with the FDA, new drug application resubmission expected mid 2025. ...
Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025. ...
Posted by Michael Wonder on 01 Apr 2025
Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti for the treatments of acute bipolar I disorder and schizophrenia
31 March 2025 - Vanda Pharmaceuticals today announced that a new drug application was submitted to the US FDA requesting marketing ...
Posted by Michael Wonder on 31 Mar 2025
Otsuka files biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
31 March 2025 - Otsuka today announce the filing of a biologics license application with the US FDA for sibeprenlimab, ...