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RSS FeedPosted by Michael Wonder on 14 Dec 2024
Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate to severe atopic dermatitis
13 December 2024 - Galderma today announced that the US FDA has approved Nemluvio (nemolizumab) for the treatment of patients 12 ...
Posted by Michael Wonder on 14 Dec 2024
FDA approves new treatment for congenital adrenal hyperplasia
13 December 2024 - Today, the US FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids to control androgen levels ...
Posted by Michael Wonder on 14 Dec 2024
FDA accepts Ascendis Pharma’s supplemental biologics license application for TransCon hGH for the treatment of adults with growth hormone deficiency
12 December 2024 - PDUFA goal date is 27 July 2025. ...
Posted by Michael Wonder on 13 Dec 2024
Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 13 Dec 2024
Stoke Therapeutics receives FDA breakthrough therapy designation for zorevunersen for the treatment of Dravet syndrome
4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...
Posted by Michael Wonder on 13 Dec 2024
Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC
4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...
Posted by Michael Wonder on 13 Dec 2024
Allay Therapeutics receives FDA breakthrough therapy designation for ATX101 for the treatment of post-surgical pain following total knee replacement surgery
4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 12 Dec 2024
Immuneering granted FDA fast track designation for IMM-1-104 in advanced melanoma
12 December 2024 - MM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative ...
Posted by Michael Wonder on 12 Dec 2024
Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US
11 December 2024 - Two Phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by ...
Posted by Michael Wonder on 12 Dec 2024
ICER announces most significant drug price hikes unsupported by new clinical evidence in US
12 December 2024 - Of 10 high expenditure drugs that had substantial 2023 net price increases, five were not supported ...
Posted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...