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RSS FeedPosted by Michael Wonder on 21 Dec 2023
Merck provides US regulatory update on gefapixant
21 December 2023 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 20 Dec 2023
Chiesi Global Rare Diseases receives FDA approval for Filzuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
19 December 2023 - Filzuvez was well tolerated and met the primary outcome with statistical significance, with 41.3% of patients ...
Posted by Michael Wonder on 20 Dec 2023
Ocugen announces OCU400 receives regenerative medicine advanced therapy designation for treatment of retinitis pigmentosa associated with RHO mutations
19 December 2023 - Ocugen today announced that the FDA has granted regenerative medicine advanced therapy designation to Ocugen’s investigational product ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health Phase 3 study results
19 December 2023 - Interim analysis results from first of its kind Phase 3 OUtMATCH study showed Xolair significantly increased the ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...
Posted by Michael Wonder on 19 Dec 2023
Texas makes a stand against big pharma’s Covid vaccines
19 December 2023 - On the last day of November Texas launched extraordinary legal proceedings that could have wide-ranging political ...
Posted by Michael Wonder on 18 Dec 2023
Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer
19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA ...
Posted by Michael Wonder on 18 Dec 2023
Lexeo Therapeutics granted FDA fast track designation and orphan drug designation for LX2020, an AAV based gene therapy candidate for PKP2 arrhythmogenic cardiomyopathy
18 December 2023 - Lexeo Therapeutics today announced the US FDA has granted fast track designation and orphan drug designation to ...
Posted by Michael Wonder on 18 Dec 2023
GC Biopharma announces US FDA approval for Alyglo (immune globulin intravenous, human-stwk) 10% liquid for adults with primary humoral immunodeficiency
18 December 2023 - - GC Biopharma today announces that the US FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% ...
Posted by Michael Wonder on 18 Dec 2023
EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for paediatric ADHD patients aged 13-17
18 December 2023 - Akili’s clinically proven digital medicine now authorised for children 8-17, opening option to more patients as ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 18 Dec 2023
Leo Pharma announces US FDA approval of Adbry (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis in paediatric patients aged 12-17 years
15 December 2023 - In the ECZTRA 6 trial, significantly more paediatric patients met the primary and key secondary endpoints of ...
Posted by Michael Wonder on 17 Dec 2023
FDA approves Arcutis’ Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older
15 December 2023 - Commercial product expected to be available by end of January. ...
Posted by Michael Wonder on 15 Dec 2023
CymaBay submits new drug application to FDA for seladelpar for the treatment of primary biliary cholangitis
15 December 2023 - New drug application is supported by data evaluating seladelpar efficacy and safety in over 500 patients. ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
15 December 2023 - Today, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for ...