Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flume Catheter.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bharat, Novavax, Nrx, Ocugen, Opiant, Tris.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rewalk Robotics.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
Compelling testimony from parents who saw life-altering changes in their children who participated in Levo Therapeutics Inc.’s intranasal carbetocin clinical trial wasn’t enough to counter what the FDA’s Psychopharmacologic Drugs Advisory Committee saw as a lack of “substantial evidence” to support the drug’s effectiveness in treating hyperphagia associated with Prader-Willi syndrome (PWS).
The FDA has granted Magstim Co. Ltd. 510(k) clearance for its transcranial magnetic stimulation (TMS) platform Horizon 3.0. TMS is a series of repetitive, focused magnetic pulses, used to stimulate brain cells. The noninvasive therapy has been touted as a cost-effective treatment for depression and is typically prescribed when antidepressants have failed, or the side effects are too disruptive to a patient’s lifestyle.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Lumos Diagnostics, Mim Software.
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
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