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RSS FeedPosted by Michael Wonder on 20 Feb 2024
PepGen receives US FDA fast track designation for PGN-EDODM1 for the treatment of myotonic dystrophy type 1
20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...
Posted by Michael Wonder on 20 Feb 2024
Disc Medicine receives FDA fast track designation for DISC-0974 for the treatment of anaemia in non-dialysis dependent chronic kidney disease
20 February 2024 - Disc Medicine today announced that the US FDA has granted fast track designation to DISC-0974 for the ...
Posted by Michael Wonder on 20 Feb 2024
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy
20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...
Posted by Michael Wonder on 20 Feb 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
Posted by Michael Wonder on 20 Feb 2024
US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
Posted by Michael Wonder on 19 Feb 2024
VivaGel BV US FDA appeal outcome
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
Posted by Michael Wonder on 19 Feb 2024
Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis
19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy ...
Posted by Michael Wonder on 19 Feb 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated advanced non-squamous non-small cell lung cancer
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
Posted by Michael Wonder on 18 Feb 2024
FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure
16 February 2024 - Today, the US FDA approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and ...
Posted by Michael Wonder on 16 Feb 2024
FDA approves osimertinib with chemotherapy for EGFR mutated non-small-cell lung cancer
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...
Posted by Michael Wonder on 16 Feb 2024
Sibeprenlimab received US FDA breakthrough therapy designation for the treatment of immunoglobulin A nephropathy
16 February 2024 - Otsuka and Visterra announce that the US FDA has granted breakthrough therapy designation for the investigational drug ...
Posted by Michael Wonder on 16 Feb 2024
Caliway received US FDA fast track designation for CBL-514 for the treatment of Dercum's disease
14 February 2024 - CBL-514 is the first drug to receive fast track designation for Dercum's disease treatment. ...
Posted by Michael Wonder on 15 Feb 2024
FDA approves tepotinib for metastatic non-small-cell lung cancer
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
Posted by Michael Wonder on 15 Feb 2024
Diamyd Medical receives US FDA fast track designation for Diamyd
15 February 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) that ...
Posted by Michael Wonder on 15 Feb 2024
Citius Pharmaceuticals resubmits the biologics license application of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...