Infinitopes has announced that the UK Medicines and Healthcare products Regulatory Agency has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company’s ‘off-the-shelf’ cancer vaccine.
Vertex Pharmaceuticals has announced that the European Commission has granted regulatory approval for a label expansion of KAFTRIO in a combination regimen with ivacaftor for the treatment of people with cystic fibrosis.
MultiOmic Health and Alloy Therapeutics have announced they have signed a Memorandum of Understanding to jointly discover and develop first-in-class renal tissue-targeting drugs.
Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for TREMFYA (guselkumab).
Domain Therapeutics has announced it has nominated and is progressing DT-9046, a candidate with "game-changing" potential in multiple inflammatory disease markets.
BrePco Biopharma (BPCO) and Piramal Critical Care (PCC) has announced that the MHRA issued a grant of a Marketing Authorisation for the use of Neoatricon.
Johnson & Johnson has announced new icotrokinra (JNJ2113) data from its comprehensive Phase 3 clinical programme and the start of the first head-to-head study in plaque psoriasis (Pso) seeking to demonstrate the superiority of an oral pill.
Centauri Therapeutics (Centauri), an immunotherapy company with a proprietary platform technology applicable across a wide range of therapeutic indications, has announced the selection of its first clinical candidate in the ABX-01 programme.
Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen's Tezspire (tezepelumab) significantly reduced nasal polyp severity.
Janssen-Cilag International NV has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of DARZALEX.
To deliver treatments for rare diseases more quickly, companies share how they are adapting their launch strategies and engaging more deeply with physicians and experts.
