FDA: Lower Levels of NDMA in Ranitidine than Previously Reported
November 4th 2019Although the levels of NDMA that was found through FDA testing are much lower than the levels that a few third-party investigators claimed, the report indicated that these levels exceed what the FDA considers acceptable for these medicines.
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FDA Clearance Given to Phase 3 Clinical Trial of Nolasiban for Women Undergoing Embryo Transfer
October 31st 2019Officials from the FDA have allowed ObsEva to begin enrolling patients in IMPLANT 3, the U.S. pivotal Phase 3 clinical trial in nolasiban in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF).
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FDA Advisory Board Votes to Recommend Withdrawing Progesterone Therapy for Preterm Birth
October 30th 2019The injection’s active ingredient, 17α hydroxyprogesterone caproate (also known as 17P), is currently the only approved treatment for pregnant women who have had a prior spontaneous preterm birth.
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FDA Approves Diroximel Fumarate for Relapsing Forms of Multiple Sclerosis
October 30th 2019Patients in a phase 3 study reported better gastrointestinal tolerability with diroximel fumarate (Vumerity) compared with dimethyl fumarate (Tecfidera) in patients with relapsing forms of multiple sclerosis.
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New Legislation for Drug Shortages Praised by Health Care Groups
October 30th 2019Multiple health care organizations, including The American Hospital Association (AHA), the Institute for Safe Medication Practices (ISMP), and the American Society of Health-System Pharmacists (ASHP), have shown their full support for the MEDS Act.
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