The Newton Massachusetts-based company, Karyopharm Therapeutics, who developed a new class of drugs to treat multiple myeloma, is in the process of submitting a new drug application to the FDA for their selinexor drug.
After watching Scott Gottlieb, M.D. of the FDA comments regarding the rebate rule changes and a warning tweet on biosimilars, AbbVie investors are bailing out. But the industry watchers claim that they don’t need to be.
Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.
EchoNous announced that it has been granted FDA 510(k) clearance for its EchoNous Vein ultrasound device which could improve peripheral IV catheter placements. This system could provide real-time clear mages of superficial and deeper veins.
Kibbutz Shefayim from an Israel-based startup company named Zebra Medical Vision announced that it has successfully received FDA clearance for an algorithm, which could aid physicians to quantify a patient’s coronary artery calcification.
The FDA sent a warning letter to Sichuan Friendly Pharmaceutical after listing it in the import alert list due to its abysmal performance during a fall inspection. The FDA was not pleased with the manufacturing methods it saw at the Chinese API maker’s facility.
The premarket approval of Pulmonx’s Zephyr Endobronchial Valve to treat severe emphysema has green-lighted by the FDA. Zephyr is a pencil eraser-sized device delivered directly to the lung in a minimally invasive procedure. After the successful delivery, the device stops air from entering diseased parts of the lung during breathing. This mechanism prevents the air from getting trapped by damaged alveoli and stops the breathing difficulties.
Epidiolex, also known as purified cannabidiol was approved to treat Lennox-Gastaut syndrome and Dravet syndrome specifically in patients aged 2 and older. Both these conditions start during childhood. Recurrent seizures pose a huge risk of death.
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