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Milestone Pharma's NDA For Cardamyst Spray Gets FDA Acceptance, Shares Up
RTT News· 9 hours agoMilestone Pharmaceuticals Inc. (MIST) Wednesday announced that the FDA has accepted the Company's New Drug Application or NDA for Cardamyst nasal spray to manage paroxysmal supraventricular tachycardia or PSVT.
Chinese firm addressing FDA concerns over Durham facility - Triangle Business Journal
The Business Journals· 1 day agoCARsgen Therapeutics has responded to observations made by the U.S. Food and Drug Administration...
FDA accepts Sanofi’s Sarclisa sBLA for priority review
Pharmaceutical Technology via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has accepted for priority review Sanofi's supplemental...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 2 days agoThe U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape ...
US FDA approves Amgen's biosimilar to AstraZeneca's rare blood disorder treatment
Reuters via Yahoo News· 22 hours agoAmgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex...
FDA greenlights pump-controlling artificial pancreas app that covers pregnant women with Type 1...
FierceBiotech· 1 day agoThe FDA delivered a green light to its first closed-loop, insulin pump-controlling smartphone app...
Accelerated Approval Process Is Not Without Risk: Placing RecentFDA Action in Context | JD Supra
JD Supra· 2 days agoOn February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for ...
FDA Warns Of Potential For Cyanide Poisoning After Apricot Seed Company Declines Recall
Tasting Table via Yahoo News· 4 days agoWhen it comes to raw apricot kernels, however, some experts have claimed that eating more than three...
Elanco Announces FDA Has Completed Review of Bovaer(R), First-in-Class Methane-Reducing Feed...
Morningstar· 21 hours agoElanco Animal Health Incorporated (NYSE:ELAN) today announced the U.S. Food and Drug Administration (FDA) has completed its comprehensive, multi-year review of Bovaer® (3- ...
FDA considers weekly insulin for diabetics - ABC Columbia
ABC Columbia· 2 days agoA U.S. Food and Drug Administration Advisory Committee is considering the benefits of a weekly...