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2. News & Events | FDA - U.S. Food and Drug Administration

   www.fda.gov/news-events

   Approvals of FDA-Regulated Products. Approval information by product type. Meetings, Conferences & Workshops. Upcoming events, past meetings, presentations, transcripts of meetings.

3. Press Announcements | FDA - U.S. Food and Drug Administration

   www.fda.gov/news-events/fda-newsroom/press-announcements

   April 29, 2024 - FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

4. Drug Approvals and Databases | FDA - U.S. Food and Drug...

   www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases

   Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products; Drug and Biologic Approval and IND Activity Reports; This Week's Drug Approvals; Drug Trials Snapshots

5. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to...

   www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes...

   FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to provide better ...

6. FDA Approves First Gene Therapies to Treat Patients with Sickle...

   www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies...

   The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older.

7. FDA Approves First COVID-19 Vaccine

   www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

   FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease ...

8. FDA Approves New Medication for Chronic Weight Management

   www.fda.gov/news-events/press-announcements/fda-approves-new-medication...

   Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg ...

9. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better...

   www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna...

   Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older.

10. COVID-19 Vaccines | FDA - U.S. Food and Drug Administration

    www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid...

    The FDA announced approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age.

11. FDA Approves Drug with New Mechanism of Action for Treatment of...

    www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism...

    Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.