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RSS FeedPosted by Michael Wonder on 29 Sep 2024
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
27 September 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 29 Sep 2024
AbbVie submits biologics license application to the FDA for telisotuzumab vedotin in previously treated non-small cell lung cancer
27 September 2024 - Biologics license application submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial ...
Posted by Michael Wonder on 28 Sep 2024
Bayer submits supplemental new drug application to US FDA seeking expanded indication for Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer
26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa ...
Posted by Michael Wonder on 27 Sep 2024
FDA grants fast track designation to PTC518 Huntington's disease program
26 September 2024 - PTC Therapeutics announced today that the FDA has granted fast track designation to the PTC518 program for ...
Posted by Michael Wonder on 27 Sep 2024
FDA approves drug with new mechanism of action for treatment of schizophrenia
26 September 2024 - Today, the US FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer voluntarily withdraws all lots of sickle cell disease treatment Oxbryta (voxelotor) from worldwide markets
25 September 2024 - Pfizer announced today that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves new drug to treat Niemann-Pick disease, type C
24 September 2024 - Today, the US FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...
Posted by Michael Wonder on 25 Sep 2024
FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...
Posted by Michael Wonder on 24 Sep 2024
Elevar Therapeutics resubmits new drug application to FDA for combination of camrelizumab plus rivoceranib as first-line treatment option for unresectable hepatocellular carcinoma boosted by CARES-310 leading overall survival analysis
23 September 2024 - Elevar Therapeutics today announced the resubmission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 24 Sep 2024
Lantern Pharma announces three US FDA rare paediatric disease designations granted to LP-184 in multiple ultra rare children’s cancers
23 September 2024 - Lantern Pharma announced today that the company has been granted three rare paediatric disease designations by the ...
Posted by Michael Wonder on 24 Sep 2024
Elevation Oncology receives fast track designation from the FDA for EO-3021 for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction cancer expressing Claudin 18.2
23 September 2024 - Elevation Oncology today announced that the US FDA has granted fast track designation to EO-3021, a differentiated ...
Posted by Michael Wonder on 24 Sep 2024
Priovant Therapeutics announces receipt of fast track designation from FDA for brepocitinib in non-anterior non-infectious uveitis
23 September 2024 - First patients have been dosed in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis. ...
Posted by Michael Wonder on 24 Sep 2024
FDA accepts Leo Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema
23 September 2024 - The application has been accepted for filing and, if approved, delgocitinib cream would become the first treatment ...
Posted by Michael Wonder on 23 Sep 2024
UCB announces US FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis
23 September 2024 - With three new indications, Bimzelx (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved ...