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Latest News & Events From The FDA

FDA Authorizes Florida’s Drug Importation Program

January 5

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


FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

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


FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder

November 9

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


FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

November 9

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


FDA Approves New Medication for Chronic Weight Management

November 8

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


FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes

October 24

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


FDA Establishes New Advisory Committee on Digital Health Technologies

October 11

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


FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants

October 3

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


FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types

September 29

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


FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests

September 29

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


FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

September 29

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


FDA Roundup: September 19, 2023

September 19

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


FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

September 11

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


FDA Roundup: September 8 2023

September 8

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


FDA Roundup: September 1, 2023

September 1

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


FDA Roundup: August 29, 2023

August 29

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


FDA Roundup: August 25, 2023

August 25

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


FDA Approves First Biosimilar to Treat Multiple Sclerosis

August 24

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


FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

August 22

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


FDA Roundup: August 18, 2023

August 18

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


FDA Roundup: August 15, 2023

August 15

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


FDA Roundup: August 11, 2023

August 11

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


FDA Roundup: August 8, 2023

August 8

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


FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

August 7

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


FDA Approves First Oral Treatment for Postpartum Depression

August 4

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


FDA Roundup: August 4, 2023

August 4

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


FDA Roundup: August 1, 2023

August 1

Silver Spring, MD / August 1, 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 and the Drug Enforcement Administration provided an update on the ongoing actions being taken to resolve the shortages of prescription stimulant medications. On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) announced that,...Read more


FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product

July 28

Silver Spring, MD / July 28, 2023 / Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and...Read more


FDA Roundup: July 28, 2023

July 28

Silver Spring, MD / July 28, 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 approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 12 months through 17 years of age. Ervebo has been approved for use in individuals 18 years of age and older since December 2019. Cases of Ebola are very...Read more


FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder

July 27

Silver Spring, MD / July 27, 2023 / Today, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders.  “The FDA continues...Read more


FDA Roundup: July 25, 2023

July 25

Silver Spring, MD / July 25, 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 reopened the comment period for the 30-day procedural notice to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods” that appeared in the Federal Register on June 15, 2023. The new deadline for comments will be...Read more


FDA Provides Update Regarding Storm Damage at Pfizer Facility in North Carolina

July 21

Silver Spring, MD / July 21, 2023 /  The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at Pfizer’s Rocky Mount, North Carolina, facility. Over the next few days, we will complete a more extensive assessment of the products that may be impacted and the current available supply of those products. This assessment also will evaluate what is in Pfizer’s other warehouses and what is...Read more


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