Private company Defender Pharmaceuticals has had its submission for a new motion sickness treatment rejected by the US Food and Drug Administration. 31 January 2024
Following on from its recent approval of Hyqvia (immune globulin) in Europe, Japanese pharma major Takeda has picked up a US approval for another CIDP product. 30 January 2024
Takeda has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP 29 January 2024
The European Commission (EC) has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) i 29 January 2024
The US supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review for patients with un 29 January 2024
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T c 26 January 2024
The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder t 26 January 2024
Products from biotech major Gilead Sciences appear twice on a US Food and Drug Administration (FDA) list of six cell therapies that are to carry black box warni 25 January 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.