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June 26, 2024
FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.
June 20, 2024
Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.
June 10, 2024
The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.
June 05, 2024
EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.
May 30, 2024
FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.
Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
April 24, 2024
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.
April 02, 2024
Plans to update the European Union’s variation framework have been finalized.
March 29, 2024
FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.
March 28, 2024
The Landos acquisition adds a lead asset in autoimmune and inflammatory disease to AbbVie's portfolio, while the company's ADC, ELAHERE, gets full FDA approval.