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The acknowledgment links the SMA gene therapy's AAV vector to tumor formation in treated children, raising fresh safety questions for the gene therapy field.
Analysts are resetting forecasts for Rasonque though executives caution it is early to judge the launch's trajectory.
Hospitals opposed the rule, which reduces drug payments under the 340B program and equalizes payments across care sites.
Sanders is likely to lead the Senate health committee and could use the PDUFA reauthorization to push drug-pricing reforms.
The suit raises questions about safety disclosures for the company's liver disease drug as it ramps up commercially.
The breakup reverses a years-long integration strategy and reshapes the footprint of one of the largest US healthcare conglomerates.
A priority review shortens the agency's timeline to decide on the BLA for the gene therapy.
The spending figure sheds light on how the industry's main trade group tries to influence public opinion amid drug-pricing debates.
The alignment sets the path for pivotal testing of the gene therapy in the inherited retinal disease.
The startup says its technology targets known but undruggable cancer targets and aims for selective autoimmune treatments.
The three-pronged cancer therapies could mark another advance in treating multiple myeloma.
The restrictions leave rare disease families and US investors facing uncertainty over the country's trial pipeline.
The decision sparked a sell-off in Nurix shares and debate over the prospects of drugs that degrade the harder-to-reach protein.
The strong numbers widen Novo's early edge over Eli Lilly in the oral weight loss market.
An infant in southwestern Wisconsin died after contracting measles, the state's first death from the disease in 36 years.
The startup is developing a medicine its investors say could reach more patients than approved drugs for myeloproliferative neoplasms.
The finalized proposal bars providers like hospitals from using third parties to deliver remote monitoring services.
The findings could help doctors choose cholesterol medicines when statins are insufficient.
The Korean company is pushing its next-generation targeted oncology candidate into the US regulatory path.
The analysis traces how biomarker tests enabled approvals based on smaller studies.
Newly approved therapies broaden treatment for rare immune conditions though patient access remains difficult.
The Trump administration is cutting off two groups that arbitrate surprise medical bill disputes.
The nonprofit-developed treatment brings an academic alternative to commercial gene therapy for the rare immune disorder.
A sickle cell gene-editing trial halted three years ago after a patient's serious adverse event may be revived.
The company's bladder cancer therapy expands into Europe with its first patient treatments.
South Korean biotech companies present blood cancer results at the major hematology meeting.
The company is positioning its CAR-T franchise and pipeline at the annual hematology meeting.
Historical data suggests the sector outperforms after midterms, with Democrats in Congress focused elsewhere.
A closer look at why shares of the Alzheimer's developer fell and whether the reaction holds up.
The new company targets the underlying cause of preeclampsia with backing from academic and industry partners.
Voters in the 2026 midterms decided health policy measures on abortion rights, marijuana laws, science bonds, and transgender youth care.
As doctors consult AI chatbots for care decisions, systems weigh new risks to patient health data and HIPAA compliance.
The measure would require regulators to act on drugs that fail government quality testing.
The court battle between a former star scientist and a younger colleague continues to divide the campus.
A drug derived from university-developed anti-cancer compounds has advanced into human testing.
The acquisition extends the company's clinical trial supply footprint in China.
A specialist discusses the FDA approval and its place in Parkinson's treatment.
The health provider is shifting toward preventive services amid rising interest in longevity medicine.
The annual awards recognized companies across immunotherapy, cancer immunology, and drug discovery.