Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celyad, Deciphera, Fosun, IMV, Inflazome, Janssen, Vanda, Verrica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Biontech, Clinigen, Cytodyn, Enzychem, Pfizer, Protokinetix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Ipsen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Anaptysbio, Assembly, Astrazeneca, Chemocentryx, Crinetics, Fate, Fujifilm, Immodulon, Leo, Merck, Mylan, Osmotica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aclaris, Asieris, Astrazeneca, Biogen, Concert, Cormedix, Croma-Pharma, Eisai, Merck, Talaris.
Cellectis SA said the FDA has placed a clinical hold on a phase I study of UCART-CS1A, an allogenic CAR T-cell therapy it has been testing in patients with relapsed or refractory multiple myeloma, after one person enrolled in the study died from a case of treatment-emergent cardiac arrest. Cellectis' chief medical officer, Carrie Brownstein, told BioWorld she supported the move, which formalized a decision she'd already taken with her team.
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