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A service for global professionals · Monday, May 5, 2025 · 809,459,358 Articles · 3+ Million Readers
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United States FDA News  •••  Topics  •  United States Media Directory

United States FDA Newswire

  • Published on May 2, 2025

    FDA expands Edwards’ TAVR to asymptomatic severe aortic stenosis

    In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis. BioWorld MedTech Regulatory …

    Source: BioWorld - Pending
  • Published on May 1, 2025

    FDA Approves Satsuma’s STS101 Nasal Powder for Acute Migraine

    The FDA has approved Satsuma’s STS101 dihydroergotamine (DHE) nasal powder under the name of Atzumi as a new treatment for adults with acute migraine, with or without aura. The approval is based on positive results from the Phase III ASCEND clinical trial …

    Source: Applied Clinical Trials - Pending
  • Published on May 1, 2025

    Recapping Every FDA Approval Announced in April for Cancer Care

    During the month of April 2025, the U.S. Food and Drug Administration (FDA) announced the approval of several agents and combination therapies in the field of oncology across indications including breast cancer, ovarian cancer, nasopharyngeal carcinoma, as …

    Source: Cure Today - Neutral
  • Published on May 1, 2025

    FDA Says “Dye Another Day” to Synthetic Colors in Snacks.

    - Advertisement - Artificial food dyes are being banned more often in the U.S., so many companies are starting to use natural dyes instead, which is generally the case in Europe. This is usually regulated at the state level, but now at least a dozen states …

    Source: The St Kitts Nevis Observer - Pending
  • Published on May 1, 2025

    FDA Sends CRL for PET Imaging Agent in Progressive/Recurrent Glioma

    The FDA has issued a complete response letter (CRL) for TLX101-CDx (18F-floretyrosine; 18F-FET; Pixclara), a PET agent designed for the characterization of progressive or recurrent glioma in adult and pediatric patients, according to a press release from …

    Source: Cancer Network - New Jersey - Pending
  • Published on May 1, 2025

    FDA Nod for J&J Autoimmune Drug is First of Potentially Many for the Projected Blockbuster Product

    A Johnson & Johnson autoimmune disease medicine that’s a relative latecomer in its drug class can now compete in its first FDA-approved indication with a label that covers a broader patient population than products already available from Argenx and UCB …

    Source: MedCity News - Neutral
  • Published on May 1, 2025

    Moderna combination flu, COVID shot delayed amid FDA scrutiny

    The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency …

    Source: BioPharma Dive - Pending
  • Published on May 1, 2025

    Petition urges FDA to reconsider a ban on ractopamine

    This week the Animal Legal Defense Fund, Center for Biological Diversity, Center for Food Safety and Food Animal Concerns Trust submitted a petition to the U.S. Food and Drug Administration to reconsider reducing or eliminating ractopamine from swine and …

    Source: National Hog Farmer - Neutral
  • Published on May 1, 2025

    FDA approves Jewel patch-wearable defibrillator

    The U.S. Food and Drug Administration has granted premarket approval to the Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD), a next-generation wearable device from Element Science designed to protect patients at temporary high risk for sudden …

    Source: Medical Economics - Neutral
  • Published on May 1, 2025

    Element Sciences earns FDA premarket approval for wearable defibrillator patch

    The Jewel Patch-WCD. [Image courtesy of Element Science]Element Science announced today that it received FDA pre-market approval for its Jewel Patch wearable cardioverter defibrillator (WCD). San Francisco-based Element Science can now bring the Jewel …

    Source: MassDevice - Neutral
  • Published on May 1, 2025

    Sen. Hawley Urges FDA to Reinstate Abortion Drug Safety Regulations

    Here is a roundup of recent pro-life and abortion-related news:Sen. Hawley urges FDA to reinstate abortion drug safety regulations Missouri Sen. Josh Hawley issued a letter on Monday urging the U.S. Food and Drug Administration (FDA) to reinstate safety …

    Source: National Catholic Register - Center-right
  • Published on May 1, 2025

    FDA Fast Tracks INX315 in Ovarian Cancer

    The FDA granted fast track status to INX-315 for the potential treatment of CCNE1-amplified, platinum-resistant/refractory ovarian cancer. INX-315 is a novel CDK2 inhibitor targeting a resistance mechanism to other therapies. INX-315 is being evaluated …

    Source: Targeted Oncology - Pending
  • Published on May 1, 2025

    FDA Clears IND of OBI-902, Trop-2 ADC for Advanced Solid Tumors

    The FDA has cleared the investigational new drug (IND) application for OBI-902. With this clearance, a phase 1/2 study in advanced solid tumors will proceed. OBI-902 is a novel Trop-2-targeting antibody-drug conjugate (ADC). The IND application for OBI …

    Source: Targeted Oncology - Pending
  • Published on May 1, 2025

    FDA Recalls Bread Containing ‘Glass Fragments’

    Over 800 cases of bread are being recalled after “glass fragments” were discovered. The U.S. Food and Drug Administration (FDA) recently categorized the incident as a Class II recall. Here’s how to tell if your bread is included in the recall and what to …

    Source: Prevention - Pending
  • Published on May 1, 2025

    Trader Joe’s salmon salad sold in New Jersey recalled

    MONROVIA, CALIF. — Taylor Fresh Foods has voluntarily recalled a limited batch of Trader Joe’s Sesame Miso Salad with Salmon due to the potential presence of an undeclared milk allergen, the company announced Monday. Roughly 500 units of the salad were …

    Source: Shore News Network - Center-right
  • Published on May 1, 2025

    Here's All 19 Ingredients in McDonald’s French Fries (And Why They're There)

    Joe Raedle / GettyBehind the Fry You might not want to know how the sausage — or the fry — is made. But somebody’s gotta spill the greasy beans. McDonald’s French fries have been the gold standard of fast food sides for decades (even if they didn't …

    Source: AOL - Pending
  • Published on May 1, 2025

    Alnylam's move into ATTR-CM with Amvuttra is a 'category growth story,' CEO says

    With attention focused on their recently approved drugs for transthyretin amyloid cardiomyopathy (ATTR-CM), there was a serendipitous timeliness to Alnylam and BridgeBio presenting their quarterly updates on consecutive days. While BridgeBio blew away …

    Source: Fierce Pharma - Neutral
  • Published on May 1, 2025

    FDA approves PRRS-resistant pig gene edit

    Animal genetics company Genus has received U.S. Food and Drug Administration (FDA) approval for its PRRS-resistant pig (PRP) gene edit for use in the U.S. food supply chain. PRRS, or porcine reproductive and respiratory syndrome, is a viral disease in pigs …

    Source: Feed Strategy - Neutral
  • Published on May 1, 2025

    FDA reinstates staff after workforce cuts spark operational challenges

    For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, including staffers who handle travel bookings for safety inspectors.More than 20 of the agency’s roughly 60 travel staff will be …

    Source: KHBS - Arkansas - Neutral
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