Catch up on the 9 FDA drug approvals most relevant to primary care, including new options for HIV-1 infection, narcolepsy, diabetes, pain management, and more.
News|Slideshows|September 26, 2024
7 Drugs Approved for Primary Care: Q3 2024
Author(s)Sydney Jennings
Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.
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As another quarter rounds out, a new batch of drugs have been approved by the US FDA for conditions often seen in primary care. Below, find details on the updated 2024-2025 formulations of mRNA COVID-19 vaccines, the first and only needle-free treatment alternative to epinephrine injection, the first orally disintegrating tablet to receive FDA approval for pregnancy prevention, and 4 more.
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The FDA accepted Organon’s MIUDELLA supplemental application, but the proposed change, supporting data, and review timeline remain undisclosed.
FDA has granted IDE approval for the STROKE-REWIRE pivotal trial evaluating NeuWire Medical's neurostimulation device for chronic ischemic stroke recovery.
The FDA accepted Bayer's sNDA and granted Priority Review to elinzanetant for vasomotor symptoms in women on endocrine therapy for HR+ breast cancer.
The FDA has approved baricitinib for adolescents aged 12 and older with severe alopecia areata, marking the first systemic oral therapy cleared for this population.
FDA approved Pfizer-BioNTech’s XFG-adapted COMIRNATY formula for adults 65 and older and high-risk people aged 5 to 64 years.
A Vaccine Integrity Project review found influenza, COVID-19, and RSV immunizations continue to protect against severe illness, hospitalization, and death.
FDA approved bictegravir/lenacapavir for adults with suppressed HIV-1 and no known or suspected component resistance.
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