U.S. Food and Drug Administration

Around the Web — 1.4.23

Under revisions announced yesterday by FDA, any pharmacy certified under the Mifepristone REMS Program can now dispense the drug. Previously, distribution was limited to certain

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Around the Web — 1.3.23

FDA last week approved ublituximab-xiiy (Briumvi, TG Therapeutics) for treating adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease,

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Around the Web — 12.28.22

The FDA is exploring ways it can regulate CBD in foods and supplements, the Wall Street Journal reports. “The FDA has approved a drug named

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Around the Web — 12.27.22

FDA last week approved lenacapavir (Sunlenca, Gilead), the first of a new capsid inhibitor class, for combination therapy in heavily treatment-experienced adults with multidrug-resistant (MDR)

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Around the Web — 12.22.22

FDA yesterday approved a new indication for tocilizumab (Actemra, Genentech) injection for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids

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Around the Web — 12.20.22

FDA yesterday released the findings and recommendations of an expert panel that evaluated the agency’s Tobacco Program. The panel assessed the Tobacco Program’s regulatory processes

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Around the Web — 12.19.22

FDA on Friday approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals A/S), a nonreplicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk

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Around the Web — 12.14.22

FDA this week granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics), a RAS GTPase family inhibitor, for adult patients with KRASG12C-mutated locally advanced or metastatic

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Around the Web — 12.07.22

Homeopathic products intended for use by those with weakened immune systems, infants and children, older adults, and pregnant women, as well as ophthalmic and injectable

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