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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Cellectis, Cybrexa, Diffusion, Endo, Mallinckrodt, Neurogene, Novartis, Otonomy, Otsuka, Propeller, Senhwa, Sosei.
Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Adial, Ascendis, CSL Behring, Daiichi Sankyo, Esperare Foundation, Gilead, Medivir, Mesoblast, Mylan, Napo, Sinovac, Viiv.
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