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RSS FeedPosted by Michael Wonder on 29 May 2025
Zydus receives US FDA fast track designation for usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis
28 May 2025 - Usnoflast has previously also received orphan drug designation from the US FDA. ...
Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab ...
Posted by Michael Wonder on 29 May 2025
Eton Pharmaceuticals announces US FDA approval for Khindivi (hydrocortisone) oral solution
28 May 2025 - Commercial launch expected the week of 2 June 2025. ...
Posted by Michael Wonder on 29 May 2025
Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease
28 May 2025 - Tryptyr is a first in class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients ...
Posted by Michael Wonder on 28 May 2025
Experimental Drug Development Centre granted US FDA fast track designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
28 May 2025 - EBC-129 is the first made in Singapore antibody-drug conjugate to enter clinical development. ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 27 May 2025
Teva celiac disease candidate granted fast track designation by US FDA
27 May 2025 - Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac ...
Posted by Michael Wonder on 27 May 2025
Savara receives refusal to file letter from the US FDA for the biologics license application for Molbreevi to treat patients with auto-immune pulmonary alveolar proteinosis
27 May 2025 - Savara today announced that the Company received a refusal to file letter from the FDA for ...
Posted by Michael Wonder on 27 May 2025
Arcutis’ Zoryve (roflumilast) 0.3% topical foam approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older
22 May 2025 - Fifth FDA approval for Zoryve in less than three years. ...
Posted 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 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 ...