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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 · 1d agoNegative↗ source
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Infectious Disease457
  • Study finds childhood platinum chemotherapy ages liver cells, may increase future cancer risk
    A new study published in Science examined children who received platinum‑based chemotherapy, such as cisplatin or carboplatin, followed by surgery for hepatoblastoma. Researchers collected samples…
    STAT · 2d agoNegative readoutNegative↗ source
  • Caspian Therapeutics launches with $50M to develop menin inhibitors for diabetes and cardiometabolic disease
    Caspian Therapeutics, a spin‑out from Kura Oncology, announced it is starting operations with $50 million in financing. The capital, led by BVF Partners and joined by Eli Lilly and Kura leadership,…
    STAT · 3d agoDealPositive↗ 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
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 4d agoPositive readoutPositive↗ source
  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 8d agoApprovalPositive↗ source
  • FDA lifts clozapine monitoring requirements, easing use for children with schizophrenia
    The Food and Drug Administration on Feb. 24, 2025 eliminated the long‑standing monitoring program that has governed clozapine for more than three decades. The change removes the extensive paperwork…
    STAT · 8d agoRegulatoryNeutral↗ source
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 9d agoRegulatoryPositive↗ source
  • Fauci warns of public "selective amnesia" on Covid, hints at upcoming book as STAT newsletter covers Trump drug pricing deals
    STAT's twice‑weekly D.C. Diagnosis newsletter continues to blend health policy analysis with behind‑the‑scenes commentary, offering readers insight into current political debates. In a recent inte…
    STAT · 9d agoNeutral↗ source
  • Pediatricians Offer 'Last Resort' Care for Vaccine-Skeptical Parents
    A small group of pediatricians across six states have created what they call a "practice of last resort" for families hesitant about vaccines. Rather than turning patients away, they focus on liste…
    STAT · 9d agoNeutral↗ source
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 10d agoCRLNegative↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 11d agoCRLNegative↗ source
  • Study finds Paxlovid ineffective for treating long Covid
    A recent study reported that the antiviral Paxlovid did not provide measurable benefit for patients suffering from long Covid symptoms. Researchers observed no significant improvement compared with…
    STAT · 11d agoNegative readoutNegative↗ source
  • House set to vote on stopgap bill that could block White House plan to politicize NIH grants
    Congressional leaders are preparing to vote on a Senate stopgap funding bill that would temporarily block the White House's proposal to place political appointees in charge of NIH research grants.…
    STAT · 11d agoRegulatoryPositive↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 12d agoDealPositive↗ source
  • FDA approves Takeda/Protagonist cancer drug Mimrylo as White House readies new drug pricing deals, BioNTech ends colon vaccine trial
    The U.S. Food and Drug Administration gave approval to a weekly injection called Mimrylo, developed by Takeda and partner Protagonist Therapeutics, for treatment of a slow‑growing cancer. The agenc…
    STAT · 12d agoApprovalNeutral↗ source
  • Trump announces nine new drug pricing agreements to align U.S. prices with peer nations
    President Trump announced a new round of voluntary pricing agreements with nine additional pharmaceutical companies, adding to the 17 firms that have previously signed similar deals. The companies…
    STAT · 12d agoDealPositive↗ source
  • Personalized mRNA melanoma vaccine shows clinical success, reviving optimism for the platform
    Moderna and Merck reported positive results from a personalized mRNA vaccine designed to treat melanoma in a recent clinical study. The outcome is being hailed as a boost for mRNA technology, whic…
    STAT · 12d agoPositive readoutPositive↗ source
  • Radiopharmaceutical experts urge pharma to adopt bolder dosing despite safety concerns
    Louise Emmett and a group of radiopharmaceutical specialists argue that these modern radiation‑based drugs could dramatically improve cancer outcomes if used more aggressively. They say the therapi…
    STAT · 12d agoNeutral↗ source
  • Pregnancy hormone explored as possible guide for cardiovascular drug development
    The STAT+ newsletter preview highlights a discussion about whether a hormone that regulates pregnancy could be leveraged to direct a new cardiovascular therapy. The piece also notes that researche…
    STAT · 12d agoNeutral↗ source
  • FDA approves Mimrylo, a weekly injection for polycythemia vera, developed by Protagonist and sold by Takeda
    The Food and Drug Administration has approved a new therapy for polycythemia vera, a rare blood cancer that causes an overproduction of red blood cells. The drug, known as rusfertide, will be mark…
    STAT · 13d agoApprovalPositive↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 14d agoApprovalPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 14d agoApprovalPositive↗ source