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The FDA granted a Breakthrough Therapy designation to olipudase alfa, but it has yet to approve the drug. Nexviadyme, branded as Nexviazyme in the U.S, is already FDA-approved. Read More
The FDA is requiring a risk evaluation and mitigation strategy (REMS) for Qsymia because of the risk of birth defects from fetal exposure during pregnancy. Read More
Gilead is seeking approval of lenacapavir for treatment of HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. Read More
The FDA outlined its latest thinking for sponsors of adjuvant therapies for renal cell and bladder cancer in two guidances released yesterday. Read More
In a letter to HHS Secretary Xavier Becerra, 100 members of Congress called for the use of several controversial federal authorities — including compulsory licensing, “march-in rights” and royalty-free rights — to help lower the prices of prescription drugs. Read More
In its latest guidance on patient-focused drug development, released yesterday, the FDA calls for high-quality clinical outcome assessments (COAs) for drug trials. Read More
Sanofi will begin offering 30-day supplies of its insulin products to uninsured patients in the U.S. for $35 on July 1, the company announced Wednesday. Read More
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