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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
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
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Infectious Disease457
  • 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
  • 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 · 1d agoNegative readoutNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 2d agoDealNegative↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 2d agoNeutral↗ 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 reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 3d agoPositive readoutPositive↗ 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
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 4d agoDealPositive↗ 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 · 7d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 8d agoPositive readoutPositive↗ 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
  • B. Braun recalls three lots of 0.9% Sodium Chloride injection due to zinc oxide particles
    B. Braun Medical Inc announced a voluntary recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB® container. The recall was triggered after testing ident…
    fda recalls · 8d agoCRLNegative↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
    FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) mult…
    fda recalls · 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 · 8d 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
  • SUPPLX.com recalls two male sexual-enhancement supplements after FDA finds undeclared yohimbine
    SUPPLX.com announced a voluntary recall of its Business Pill and Branch Manager for Men supplements after FDA laboratory analysis detected undeclared yohimbine in both products. Yohimbine is a pre…
    fda recalls · 9d agoCRLNegative↗ 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
  • 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
  • Mid-size biotechs join White House Medicaid pricing program, gain tariff relief
    Nine mid-size drugmakers announced they will take part in the White House’s GENEROUS Medicaid pricing model, which ties U.S. Medicaid payments to the lowest prices paid abroad. In return, the comp…
    BioPharma Dive · 11d agoRegulatoryNeutral↗ source
  • FDA clears Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera, opening potential $2 billion market
    The Food and Drug Administration has granted clearance to rusfertide, sold under the brand name Mimrylo, for the treatment of polycythemia vera, a rare blood disorder that causes excess red blood c…
    BioPharma Dive · 12d agoApprovalPositive↗ source
  • Cytokinetics reports Phase 3 success for Myqorzo but shares tumble as investors weigh market impact
    At the European Society of Cardiology meeting, Cytokinetics presented Phase 3 data for Myqorzo in non‑obstructive hypertrophic cardiomyopathy, showing benefit in both forms of the disease and disti…
    BioPharma Dive · 12d agoPositive readoutNeutral↗ source