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RSS FeedPosted by Michael Wonder on 16 Feb 2024
FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
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 ...
Posted by Michael Wonder on 15 Feb 2024
Dermavant submits supplemental new drug application to FDA for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
14 February 2024 - sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials ...
Posted by Michael Wonder on 14 Feb 2024
Rocket Pharmaceuticals announces update on FDA review timeline of Kresladi (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I
13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...
Posted by Michael Wonder on 14 Feb 2024
Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the US and EU
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
Posted by Michael Wonder on 14 Feb 2024
FDA approves first medication to treat severe frostbite
14 February 2024 - The US FDA approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk ...
Posted by Michael Wonder on 14 Feb 2024
US FDA accepts for priority review Bristol Myers Squibb’s application for Augtyro (repotrectinib) for the treatment of patients with NTRK positive locally advanced or metastatic solid tumours
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted by Michael Wonder on 13 Feb 2024
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
Posted by Michael Wonder on 13 Feb 2024
Edgewise receives US FDA fast track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy
13 February 2024 - Edgewise Therapeutics today announced that the US FDA has granted fast track designation for EDG-5506 for the ...
Posted by Michael Wonder on 13 Feb 2024
The threat of fungal infections is growing. Why is it so hard to make new drugs?
11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...