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FDA Alerts

FDA ALERT
FDA Alert
FDA ALERT
FDA Approves First Activin Signaling Inhibitor Therapy in Patients with PAH
04/12/2024

Jessica Bard

Jessica Bard
The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...
04/12/2024
FDA Alert
Fda alert
FDA Alert
FDA Approves First Oral Medication for Treatment of Postpartum Depression
10/04/2023

Jessica Ganga

Jessica Ganga
Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.
10/04/2023
FDA Alert
fda alerts
FDA Alert
As Infections Increase, FDA Approves Updated Vaccines to Protect Against COVID-19 Variants
09/15/2023

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.
09/15/2023
FDA Alert
fda
FDA Alert
FDA Approves First RSV Vaccine For Pregnant Individuals
08/24/2023

Anthony Calabro, MA

Anthony Calabro, MA
Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
08/24/2023
Arthritis
Arthritis
FDA Approves Treatment Option for Polyarticular Course JIA
10/01/2020
A Janus kinase inhibitor was approved for the treatment of active polyarticular course juvenile idiopathic arthritis among patients aged 2 years or older.
10/01/2020
FDA
FDA
FDA Approves Treatment Option for Polyarticular Course JIA
07/20/2020
The US Food and Drug Administration has approved tofacitinib for the treatment of active polyarticular course juvenile idiopathic arthritis among pediatric patients aged 2 years or older.
07/20/2020
smoking
smoking
FDA Requires New, Larger Cigarette Warnings
03/18/2020
The Food and Drug Administration has issued a final rule requiring new health warnings on cigarette packaging and advertisements.
03/18/2020
FDA
FDA
FDA Approves New Acute Treatment for Migraine With or Without Aura
12/26/2019
It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
12/26/2019
smoking
smoking
FDA Warns Against THC, Vitamin E Acetate in Vaping Products
09/10/2019
The FDA have identified several ingredients that may be connected to the recent reports of individuals with severe respiratory illness in connection with use of electronic smoking products.
09/10/2019
smoking
smoking
FDA Limits Flavored E-Cig Sale Following Significant Increase in Use
11/16/2018
In response to the release of a CDC report detailing increases in the use of e-cigarettes among youth in the US between 2011 and 2018, the FDA has released a statement detailing new limitations to the sale...
11/16/2018