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RSS FeedPosted by Michael Wonder on 26 May 2025
Otsuka announces FDA acceptance and priority review of biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
26 May 2025 - Otsuka Pharmaceutical today announce the US FDA has accepted for review the biologics license application for ...
Posted by Michael Wonder on 25 May 2025
Moderna files FDA application for the LP.8.1 targeting COVID-19 vaccine
23 May 2025 - Moderna today announced that it has submitted an application to the US FDA for review of its ...
Posted by Michael Wonder on 25 May 2025
Xbrane Biopharma updates on US FDA biologics license application for its investigational biosimilar candidate to Lucentis (ranibizumab)
23 May 2025 - Xbrane re-submitted the biologics license application) for its investigational biosimilar candidate to Lucentis (ranibizumab) to the US ...
Posted by Michael Wonder on 24 May 2025
US FDA approves Liquidia’s Yutrepia (treprostinil) inhalation powder for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease
23 May 2025 - Yutrepia is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. ...
Posted by Michael Wonder on 23 May 2025
Relief Therapeutics receives FDA rare paediatric disease designation for RLF-TD011
22 May 2025 - Relief Therapeutics today announced that the US FDA has granted rare paediatric disease designation to RLF-TD011 ...
Posted by Michael Wonder on 22 May 2025
FDA approves Genentech’s Susvimo for diabetic retinopathy
22 May 2025 - Genentech announced today that the US FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment ...
Posted 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
Belite Bio announces FDA granting of breakthrough therapy designation for tinlarebant for the treatment of Stargardt disease
21 May 2025 - Belite Bio today announced that the US FDA has granted breakthrough therapy designation for tinlarebant for ...
Posted by Michael Wonder on 21 May 2025
FDA takes steps to enhance state importation programs to help lower prescription drug prices
21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and ...
Posted by Michael Wonder on 21 May 2025
Moderna provides update on BLA submission for combination vaccine against influenza and COVID-19
21 May 2025 - Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the ...
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 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 ...