Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 May 2025
FDA takes steps to enhance state importation programs to help lower prescription drug prices
21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and ...
Posted by Michael Wonder on 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
Posted by Michael Wonder on 17 May 2025
PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025
16 May 2025 - PharmaTher today announced the US FDA has extended the approval goal date for the review of ...
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 ...
Posted by Michael Wonder on 16 May 2025
Kaerus Bioscience's lead candidate KER-0193 granted orphan drug designation and rare paediatric drug designation by US FDA for treatment of Fragile X syndrome
14 May 2025 - Kaerus Bioscience today announces that its lead candidate KER-0193 has been granted both orphan drug designation and ...
Posted by Michael Wonder on 16 May 2025
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...
Posted by Michael Wonder on 15 May 2025
FDA sets PDUFA date for Xspray Pharma’s re-submitted application for Dasynoc
14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc. ...
Posted by Michael Wonder on 15 May 2025
FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...