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RSS FeedPosted by Michael Wonder on 07 Jul 2024
FDA approves Genentech’s Vabysmo pre-filled syringe for three leading causes of vision loss
4 July 2024 - Vabysmo PFS is the first and only syringe pre-filled with an FDA approved bi-specific antibody to treat ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 06 Jul 2024
Submission of Nidlegy marketing authorisation application validated by EMA
4 July 2024 - The assessment period of the dossier by the authorities has started on 20 June. ...
Posted by Michael Wonder on 05 Jul 2024
Hinova Pharmaceuticals receives FDA fast track designation for HP518 for treatment of androgen receptor triple-negative breast cancer
5 July 2024 - Hinova Pharmaceuticals today announced that the US FDA has granted fast track designation for HP518, an investigational ...
Posted by Michael Wonder on 05 Jul 2024
Tagrisso with the addition of chemotherapy approved in the EU as new first-line treatment for patients with EGFR-mutated advanced lung cancer
5 July 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 04 Jul 2024
Checkpoint Therapeutics announces biologics license application resubmission for cosibelimab
2 July 2024 - Checkpoint Therapeutics today announced it has completed the resubmission of its biologics license application to the US ...
Posted by Michael Wonder on 04 Jul 2024
Full-Life Technologies granted FDA fast track designation for 225Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer
2 July 2024 - Full-Life Technologies today announced that the US FDA has granted fast track designation for 225Ac-FL-020, the company's ...
Posted by Michael Wonder on 04 Jul 2024
Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
Inozyme Pharma announces FDA fast track designation for INZ-701 in ABCC6 deficiency
2 July 2024 - Inozyme Pharma today announced that the US FDA has granted fast track designation to INZ-701 for ...
Posted by Michael Wonder on 03 Jul 2024
Kye Pharmaceuticals announces the availability of Quillivant ER chewable tablets for the treatment of children with ADHD
2 July 2024 - Quillivant ER chewable tablets are the first and only extended release chewable methylphenidate tablets approved in Canada. ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...
Posted by Michael Wonder on 03 Jul 2024
Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout
2 July 2024 - Sobi today announced the initiation of a rolling biologics license application to the US FDA for SEL-212. ...
Posted by Michael Wonder on 03 Jul 2024
"99mTc-maraciclatide" granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis
2 July 2024 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as a ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...