In January 2022, Omnipod 5 was first approved for anyone over six. Omnipod 5 is the first tubeless automated insulin delivery (AID) made available in the United States for a broad age range. Recently,...
On August 19, 2022, the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults. This medication...
Alongside Kyleena and Liletta, Mirena is one of three hormonal intrauterine devices (IUD) available in the United States. Previously, the duration of use for Mirena was seven years, at which point the...
The Biden Administration is preparing for a potential coronavirus surge this fall by purchasing millions of variant-specific COVID-19 booster shots. In addition to the 105 million doses already...
On August 17, 2022, the FDA approved bluebird bio's Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy to treat patients with beta thalassemia who need regular red blood...
On July 13, 2022, the FDA issued an Emergency Use Authorization (EUA) for the Novavax COVID vaccine. Following this approval, the CDC added the Novavax COVID vaccine to their recommended vaccines for...
Recently, the FDA approved a new second-line treatment for large B-cell lymphoma (LBCL). Lisocabtagene maraleucel is the generic name for Breyanzi, developed and marketed by Juno Therapeutics. As a...
Recently, the FDA approved Qsymia for chronic weight management in pediatric patients over 12 years old. Qsymia is an extended-release pill composed of phentermine and topiramate. The drug’s...
The FDA recently approved Skyrizi as a treatment for moderate to severely active Crohn’s disease. Crohn’s disease is an inflammatory bowel disease (IBD) with many painful symptoms that can...
The FDA recently approved the Imcivree (setmelanotide) injection as a weight-management treatment for adults and children over 6 with Bardet–Biedl Syndrome (BBS). BBS is a relatively...
On June 15, the FDA advisory board unilaterally voted to approve Pfizer’s COVID vaccine for children under 5. Until now, there has been a gap in COVID-related care for children under 5 as...
Monday’s FDA approval of Olumiant for the treatment of Alopecia Areata (AA) marks a historical change in the procedures used to address Alopecia Areata as it is the first systemic therapy for the...
Last week, the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 15 – 0, concluding that the benefits of bluebird bio’s gene therapy to treat cerebral...
Earlier this month, the FDA approved GSK’s Priorix measles, mumps, and rubella (MMR) vaccine in the United States for individuals 12 months and older.
MMR vaccines are recommended in a...
Late last month, Pfizer announced its coronavirus vaccine clinical trial results, indicating that a three-dose regimen of the Pfizer-BioNTech vaccine was safe and effective for children older than 6...
Novartis’s Kymriah was granted accelerated FDA approval last week after the drug’s clinical trial results demonstrated an 86% overall response rate and a high level of safety. Patients with...
Sanofi’s Dupixent received FDA approval for use in people suffering from eosinophilic esophagitis (EoE) after a double-blind, placebo-controlled trial proved the drug effectively reduces...
The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors...
FDA recently approved AstraZeneca’s Ultomiris to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
The agency based the...
Today, the FDA is proposing a total ban on flavored cigarettes and cigars, citing their link to increased rates of addiction in young people and their elevated risk of enhanced effects on the...
