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US FDA staff says Guardant’s test may fail to detect some pre-cancerous tumors
WHTC 1450 Holland· 6 hours ago(Reuters) -The U.S. Food and Drug Administration's staff reviewers on Tuesday raised concerns that...
Arnold & Porter Hires Former FDA Counsel Eva Temkin as Partner
Bloomberg Law· 6 hours agoEva Temkin has joined Arnold & Porter as a partner with the firm’s life sciences and healthcare regulatory practice in Washington, the firm said Tuesday.
FDA Approves Pivya, a New Treatment for UTIs in Women
Health.com· 1 day agoCompared to complicated UTIs, uncomplicated ones are less severe and more prevalent, affecting more...
DURECT Corporation Receives FDA Breakthrough Therapy Designation for Larsucosterol in...
WTRF Wheeling· 9 hours agoFood and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to larsucosterol for the treatment of patients with severe alcohol-associated hepatitis ...
FDA OK’s Elon Musk’s Neuralink to implant brain chip into second patient: report
NY Post via Yahoo News· 1 day agoNews of the FDA’s approval was first reported by The Wall Street Journal on Monday. Neuralink has...
FDA Greenlights Elon Musk’s Neuralink to Take Major Step Forward
The Daily Beast· 1 day agoThe U.S. Food and Drug Administration has cleared Elon Musk’s company Neuralink to implant a second...
FDA Grants Withdrawal of Infigratinib for Cholangiocarcinoma
Medscape· 16 hours agoThe US Food and Drug Administration (FDA) has announced the withdrawal of its 2021 accelerated approval of infigratinib (Truseltiq) for patients with a certain type of previously ...
Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S....
WTRF Wheeling· 9 hours agoFood and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI ...
FDA sued by scientist urging sexual side effects warning for widely used depression drugs
Reuters· 1 day agoCsoka was one of 22 scientists who filed the so-called citizen petition with the FDA in May 2018,...
FDA approves self-collection screening for virus that causes cervical cancer
U-T San Diego· 8 hours agoThe Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health ...