Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Global Blood Therapeutics, Immune, Immunic, Immuron, Revive, Saniona.
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Arch, Cassi, Cytodyn, Enochian, Heat, Helsinn, Insmed, Kiniksa, Lupin, Sound, Taiho.
The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baylx, Genmab, Lupin, Macrogenics, Merck, Moleculin, Mylan, Oncolys, Pharmaessentia, Polyneuron.
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Algernon, Anavex, Can-Fite, Elixirgen.
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