Food and Drug Administration (FDA)
NEWS
Companies are still developing and refining treatments and preventions for COVID-19, but not all of them are approved or authorized. Here’s a look at the latest COVID-19 news.
Amarin released disappointing post hoc data from a sub-study of the REDUCE-IT trial, showing that its fish oil-derived Vascepa had little impact on serum biomarkers.
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
As the nation reacts to the overturning of Roe v. Wade, pharma companies must address the changes in demand for drugs and services, all while navigating increasingly muddy legal waters.
Axsome hosted an investor day event to provide an update on plans for Sunosi and other developmental assets, including MDD treatment AXS-05.
Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
The Phase III study of Jazz Pharmaceuticals cannabis-derived MS Sativex failed to achieve the primary endpoint of an improvement in muscle tone in patients.
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