FDA

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...

Vertex’s Journavx Approved by FDA, Offers Hope for Opioid Alternatives

31 Jan 2025

The FDA approved a new pain medication designed to reduce the risks of addiction and overdose linked to opioids like Vicodin and OxyContin on Thursday. The drug, called Journavx, was developed by Vertex Pharmaceuticals and targets short-term pain following surgery or injury. A New Approach to Pain Relief Journavx offers...

FDA Approves Monthly Dosing for Leqembi, Boosting Alzheimer’s Treatment Accessibility

28 Jan 2025

The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi, an Alzheimer's drug developed by Japan's Eisai in partnership with Biogen. This approval marks a significant milestone in Alzheimer's treatment, providing a more convenient dosing schedule for patients. Leqembi, which received standard approval from the FDA...

FDA Recalls Dapsone Gel: 23,000 Bottles Pulled Over Safety Concerns

23 Jan 2025

The United States Food and Drug Administration (FDA) has issued a recall for 23,304 bottles of Dapsone Gel 7.5%, an acne treatment, due to crystal formation in the product. This issue raises significant concerns over its effectiveness and safety, urging consumers to stop using the product immediately and consult their...

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