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RSS FeedPosted 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
PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation
20 September 2024 - An appeals court revived the case and sent it back to a lower court in Texas. ...
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 ...
Posted by Michael Wonder on 22 Sep 2024
Inside the quiet strategy pharma giants are using to fend off generics and drive up the cost of medicines
18 September 2024 - Amid debate over potential abuse of the US patent system by the pharmaceutical industry, moves by ...
Posted by Michael Wonder on 22 Sep 2024
Ethical challenges associated with pragmatic and cluster RCTs
14 September 2024 - Pragmatic and cluster RCTs offer opportunities for advancing research but present ethical challenges. ...
Posted by Michael Wonder on 21 Sep 2024
FTC accuses drug middlemen of inflating insulin prices
20 September 2024 - Agency files lawsuit alleging firms profited from higher insulin prices. ...
Posted by Michael Wonder on 21 Sep 2024
The price war in weight loss drugs is here
20 September 2024 - Novo Nordisk and Eli Lilly are offering discounts to encourage more insurance coverage of the medicines. ...