Silver Spring, MD / January 5, 2024 / Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Through this pathway, the FDA may authorize section...Read more
Silver Spring, MD / December 8, 2023 / Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative...Read more
Silver Spring, MD / November 9, 2023 / Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder. “The FDA remains deeply committed in our...Read more
Silver Spring, MD / November 9, 2023 / Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of...Read more
Silver Spring, MD / November 8, 2023 / 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/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol) for use, in...Read more
Silver Spring, MD / October 24, 2023 / Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This is the first targeted therapy approved for this indication. The agency also approved the Abbott RealTime IDH1 Assay as a...Read more
Silver Spring, MD / October 11, 2023 / Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and...Read more
Silver Spring, MD / October 3, 2023 / Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to...Read more
Silver Spring, MD / September 29, 2023 / Today, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer....Read more
Silver Spring, MD / September 29, 2023 / Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years. LDTs are in vitro diagnostic products...Read more
Silver Spring, MD / September 29, 2023 / Today, the U.S. Food and Drug Administration is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. The agency is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing clinical development issues. “We...Read more
Silver Spring, MD / September 19, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA informed the public in the Prostate Cancer Symptoms, Tests and Treatments Consumer Update that the agency regulates certain tests and treatments for prostate cancer to ensure they are safe and effective. Prostate cancer is the most common cancer among men...Read more
Silver Spring, MD / September 11, 2023 / Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and...Read more
Silver Spring, MD / September 8, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s Center for Devices and Radiological Health (CDRH) published a Postmarket Device Safety-Related Communications Report to Congress. CDRH strives to provide current information concerning the benefits and risks of marketed medical devices to health care...Read more
Silver Spring, MD / September 1, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected...Read more
Silver Spring, MD / August 29, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA informed consumers in Treating and Dealing with ADHD about FDA-approved treatments to help reduce the symptoms of attention-deficit/hyperactivity disorder, also known as ADHD, and improve functioning in children as young as age 6 years old. On Friday,...Read more
Silver Spring, MD / August 25, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the signing of a first-of-its kind Regulatory Partnership Arrangement with Ecuador’s seafood regulatory authority to enhance the safety of shrimp imported to the United States. On Thursday, the FDA issued a proposed External Link...Read more
Silver Spring, MD / August 24, 2023 / The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD)...Read more
Silver Spring, MD / August 22, 2023 / Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. Abrysvo...Read more
Silver Spring, MD / August 18, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA provided an update to the list of ultraviolet (UV) wand products that may present a risk of injury. Do not use these UV wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury...Read more
Silver Spring, MD / August 15, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for information on a citizen petition asking the FDA to amend the standard of identity for pasteurized orange juice by lowering the minimum soluble solids content, known as the Brix level. Comments are due by October 16,...Read more
Silver Spring, MD / August 11, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued an Outbreak Advisory for an investigation of Listeria monocytogenes potentially linked to ice cream. The FDA advises consumers, restaurants, and retailers not to eat, sell, or serve recalled Real Kosher Ice Cream Soft Serve On The Go ice cream...Read more
Silver Spring, MD / August 8, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced it is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe...Read more
Silver Spring, MD / August 7, 2023 / Today, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the FDA. This includes a wide range of products such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body...Read more
Silver Spring, MD / August 4, 2023 / Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider...Read more
Silver Spring, MD / August 4, 2023 / Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a new guidance for immediate implementation, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” which provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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