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RSS FeedPosted 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
Voucher program notches win as clock ticks
20 September 2024 - The FDA’s priority review voucher program for rare paediatric diseases is set to lapse on 30 September ...
Posted by Michael Wonder on 21 Sep 2024
FDA fast track designation for narmafotinib in advanced pancreatic cancer
19 September 2024 - Amplia Therapeutics is pleased to announce that the US FDA has granted fast track designation to Amplia's ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves nasal spray influenza vaccine for self or caregiver administration
20 September 2024 - First influenza vaccine that does not need to be administered by a health care provider. ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
20 September 2024 - Today, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves first treatment for Niemann-Pick disease, type C
20 September 2024 - Today, the US FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type ...
Posted by Michael Wonder on 19 Sep 2024
FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
19 September 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for adult patients with locally ...
Posted by Michael Wonder on 19 Sep 2024
FDA declines to approve Vanda's marketing application for tradipitant in gastroparesis
19 September 2024 - - Vanda Pharmaceuticals today provided an update on its tradipitant development program. ...
Posted by Michael Wonder on 19 Sep 2024
Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors
18 September 2024 - Azitra today announced the US FDA has granted fast track designation for topically applied ATR-04 to treat ...