Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 10 Jun 2025
US FDA approves Merck’s Enflonsia (clesrovimab-cfor) for prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season
9 June 2025 - Enflonsia is the first and only RSV preventive option administered to infants using the same dose ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 01 Jun 2025
Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE
31 May 2025 - mNEXSPIKE becomes Moderna's third FDA approved product. ...
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 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 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 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
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 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 16 May 2025
Amneal receives US FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults
15 May 2025 - Product will be available for appropriate patients in the second half of 2025 ...