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RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 21 Dec 2023
RemeGen announces continued inclusion of telitacicept and disitamab vedotin in China National Reimbursement Drug List, ensuring continuous accessibility of innovative drugs for more patients
18 December 2023 - RemeGen has recently confirmed that under the 2023 simple renewal mechanism of China National Healthcare Security ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
Posted by Michael Wonder on 21 Dec 2023
Johnson & Johnson submits supplemental biologics license application and new drug application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus lazertinib for the treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful ...
Posted by Michael Wonder on 21 Dec 2023
4DMT receives FDA regenerative medicine advanced therapy designation for 4D-150 genetic medicine for intravitreal treatment of wet AMD, the first RMAT designation in wet AMD
21 December 2023 - Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and ...
Posted by Michael Wonder on 21 Dec 2023
Calliditas Therapeutics announces full FDA approval of Tarpeyo, the only FDA approved treatment for IgA nephropathy to significantly reduce the loss of kidney function
20 December 2023 - Calliditas Therapeutics today announced that the US FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce ...
Posted 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 21 Dec 2023
Ravulizumab for the treatment of patients with AQP4 antibody positive neuromyelitis optica spectrum disorder
20 December 2023 - NICE is unable to make a recommendation on the use of ravulizumab (Ultomiris) for the treatment of ...
Posted by Michael Wonder on 21 Dec 2023
Future supply of new COVID-19 vaccines confirmed
20 December 2023 - A vaccine to combat the newer strains of COVID-19 has been approved and will be available ...
Posted by Michael Wonder on 20 Dec 2023
Empagliflozin for the treatment of patients with chronic kidney disease
20 December 2023 - NICE has published evidence-based recommendations on the use of empagliflozin (Jardiance) for the treatment of adults ...
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
Budesonide for the treating primary IgA nephropathy
20 December 2023 - NICE has published evidence-based recommendations on the use of budesonide (Kinpeygo) for the treatment of adults ...
Posted by Michael Wonder on 20 Dec 2023
Ravulizumab for the treatment of patients with generalised myasthenia gravis
20 December 2023 - NICE is unable to make a recommendation on the use of ravulizumab (Ultomiris) for the treatment of ...
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 ...