Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dib Ultranav Medical, Franklin Mountain Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Astrazeneca, Autolus, Langsheng, Merck & Co., Obseva, Priothera, Quoin, Roche, Sol-Gel, Sorrento, Valneva.
There may be no COVID-19 vaccines authorized yet in the U.S. for the youngest children, but there’s now an approved treatment for some children who are already sick with an infection.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conextions.
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon.
Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis.
Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Direct, Incyte, Lynk, Medac, Medexus, Novartis, Revance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridge to Life, Qvella.
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
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