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97 stories matching this filter · ← front page

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  • FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGs
    The U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…
    STAT · 1d agoRegulatoryPositive↗ source
  • Boycott Targeting American Diabetes Association Expands to Include Medical Journal
    A new boycott has been launched against the American Diabetes Association (ADA). The campaign also calls on a medical journal to join the effort, signaling broader criticism of the organization. T…
    STAT · 22h agoNegative↗ source
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Endocrinology & Metabolism493
Infectious Disease456
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 2d agoCRLNeutral↗ source
  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Massachusetts governor warns early-stage biotech firms of capital crunch ahead of election
    Massachusetts Governor Maura Healey visited the MassBio headquarters in Cambridge, meeting with roughly 50 CEOs of early-stage biotech companies. The gathering, held on a Wednesday afternoon, was i…
    Fierce Biotech · 2d agoNegative↗ source
  • FDA approves Revolution Medicines’ pancreatic cancer drug Rasonque, but patients face delayed access
    The U.S. Food and Drug Administration has granted approval to Rasonque, a new therapy for pancreatic cancer developed by Revolution Medicines. The decision follows clinical data that showed the dru…
    STAT · 4d agoApprovalNeutral↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 4d agoCRLNegative↗ source
  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • Boston Scientific recalls Infinion CX spinal cord stimulator leads over risk of mechanical stress and fracture
    Boston Scientific issued a recall of its Infinion CX spinal cord stimulator leads after identifying a risk of mechanical stress at the anchor site that can cause high impedance readings or lead fra…
    fda medwatch · 9d agoCRLNegative↗ source
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 8d agoNeutral↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Opinion: Trump administration’s paperwork surge hampers science and health care
    The opinion piece argues that the Trump administration has expanded paperwork requirements, making it harder for scientists and Medicaid recipients to access services. Citing a federal estimate th…
    STAT · 11d agoNegative↗ source
  • Dietitian Shortage Threatens Trump Administration's Nutrition Initiatives
    The Trump administration's Make America Healthy Again (MAHA) plan has shifted nutrition guidance, promoting more protein, cutting processed foods, and revamping meals in schools, military bases and…
    STAT · 11d agoNegative↗ source
  • New American Headache Society guidelines highlight expanded migraine prevention options
    The American Headache Society and the American Academy of Neurology released updated guidance on migraine prevention, the first revision since 2012. The new recommendations note that the FDA has a…
    STAT · 11d agoRegulatoryPositive↗ source
  • Medicare’s G2211 billing code for relationship-based primary care falls short of expectations
    The Medicare G2211 billing code, added in 2024, lets doctors add $16 to each visit when they provide comprehensive, relationship‑based primary care. It was meant to reward the broader set of servic…
    STAT · 15d agoRegulatoryNegative↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 16d agoRegulatoryNegative↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 16d agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 17d agoApprovalPositive↗ source
  • AI can flag drug theft in hospitals, but alerts need human follow-up, case shows
    In September 2024, a travel nurse at Adventist Health in Bakersfield, California, was observed behaving erratically and was later found to be diverting opioids from a secured cabinet, documenting t…
    STAT · 18d agoNeutral↗ source
  • Cancer screening guidelines overlook residents of long-term care facilities, expert warns
    Kim Johnson, a cancer epidemiologist at Washington University, reflects on the lack of screening guidance for people living in long‑term care after her aunt's death. Her aunt, 78, entered a care f…
    STAT · 18d agoNegative↗ source
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda medwatch · 19d agoCRLNegative↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 19d agoPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 22d agoDealPositive↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 22d agoRegulatoryNegative↗ source
  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 21d agoDealNeutral↗ source