FDA

Novavax COVID-19 Shot Wins Full FDA License, But With Strict Age and Risk Limits

18 May 2025

The US Food and Drug Administration has fully approved Novavax's COVID-19 vaccine. But it is done with uncommon limitations. In contrast to its rivals Pfizer and Moderna, Novavax is now only allowed to provide its vaccine to people 65 and over—or individuals 12 to 64 with a high-risk medical condition....

Peter Marks Resigns as FDA Vaccine Chief, Slams Kennedy for Spreading ‘Misinformation’

29 Mar 2025

Dr. Peter Marks, a leading vaccine expert at the U.S. Food and Drug Administration (FDA), resigned on Friday, citing Health Secretary Robert F. Kennedy Jr.'s alleged spread of "misinformation and lies" about vaccines. In the resignation letter, Peter Marks condemned Kennedy’s aggressive rhetoric against vaccines, calling it "irresponsible" and a...

FDA Issues 2025-26 Flu Vaccine Recommendations Without Independent Adviser Input

17 Mar 2025

The U.S. Food and Drug Administration (FDA) recently announced its recommendations for the composition of the 2025-26 influenza vaccine, making this decision without the usual input from its independent vaccine advisers. This move follows the unexpected cancellation of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, which...

FDA Approves First Myasthenia Gravis Treatment for Children

13 Mar 2025

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) for children aged six and older with generalized myasthenia gravis (gMG), marking the first treatment available for pediatric patients with this challenging autoimmune neuromuscular disorder. This decision brings a ray of hope to families affected...

RFK Jr Orders FDA to Close Food Safety Loophole

11 Mar 2025

In a landmark move, the US Secretary of Health and Human Services, Robert F. Kennedy Jr., has directed the Food and Drug Administration (FDA) to overhaul its “self-affirm” rule, which allows food companies to introduce ingredients without official FDA notification or approval. Kennedy’s decision aims to close this regulatory loophole,...

FDA Approves New Stroke Treatment: Faster Clot-Busting Drug TNKase

07 Mar 2025

The U.S. Food and Drug Administration (FDA) has approved tenecteplase (TNKase) as a groundbreaking treatment for acute ischemic stroke (AIS), marking the first new clot-busting drug in nearly 30 years. Stroke remains a leading cause of death and disability, affecting over 795,000 people annually in the United States alone. This...

FDA Approves Gomekli: First Treatment for NF1 Tumors in Adults and Children

13 Feb 2025

On February 11, 2025, the U.S. Food and Drug Administration (FDA) approved SpringWorks Therapeutics' drug, Gomekli (mirdametinib), for the treatment of neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN). This approval applies to both adults and children aged two years and older who have tumors that cannot be surgically...

FDA Greenlights Emblaveo: A New Weapon Against Drug-Resistant Infections

08 Feb 2025

The U.S. Food and Drug Administration (FDA) has granted approval for a new treatment for complicated intra-abdominal infections (IAIs), a class of infections that affect millions of people globally every year. This new drug, Emblaveo, co-developed by pharmaceutical giants AbbVie and Pfizer, offers a promising solution for these infections, particularly...

FDA Approves Game-Changing Non-Opioid Painkiller to Fight Addiction Crisis

31 Jan 2025

The United States Food and Drug Administration (FDA) recently approved a new non-opioid drug, Journavx, developed by Vertex Pharmaceuticals, which represents a groundbreaking shift in pain management. This approval marks a significant milestone in the ongoing effort to combat the opioid crisis that has plagued the country for over two...

FDA Upgrades Lay’s Classic Chips Recall Over Undeclared Milk Ingredient

31 Jan 2025

In December, the US Food and Drug Administration (FDA) announced a recall notice for Lay's Classic Potato Chips because a consignment of this popular snack is suspected to have undeclared milk ingredients. That recall notice has just been promoted to 'Class I,' the highest degree of risk. It poses such...

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