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Rhythm | December 01, 2020
Stoutness is a significant issue around the world, in any case, for a small amount of patients, hereditary changes instead of propensities are driving the sickness. With its new FDA endorsement for Imcivree, Rhythm Pharmaceuticals is venturing out treating those cases.
For a subset of heftiness patients, hereditary transformations leave them with an "voracious appetite," Rhythm CEO David Meeker, M.D., said in a meeting. Beginning stage hereditary illnesses can leave pati...
JelikaLite Corp | January 07, 2022
JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age.
The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irre...
Medexus Pharmaceuticals | July 13, 2021
Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada.
Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it.
Antares Pharma, Inc. | February 04, 2022
Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act.
TLANDO® was granted tentative approval from the FDA as a twice-daily...
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