The rule reduces reimbursement for drugs purchased under the 340B discount program and equalizes payments across care sites, drawing strong opposition from hospitals.
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The disclosure adds to scrutiny of the safety profile of the one-time gene therapy, one of the most widely used treatments for spinal muscular atrophy.
The filing sets up a regulatory decision on what would be a first gene therapy for the inherited neurodegenerative disease, though approval remains uncertain.
Early sales blew past Wall Street expectations, prompting analysts to reset projections for the drug despite company caution about drawing conclusions too soon.
The lawsuit raises questions about safety disclosures for the first approved treatment for MASH liver disease.
The breakup reverses years of vertical integration in healthcare and challenges the assumption that larger conglomerates deliver better results.
The oral obesity drug's strong numbers widen Novo's early lead over Eli Lilly in the pill segment of the weight loss market.
The decision triggered analyst debate over the prospects of drugs designed to degrade the hard-to-target STAT6 protein.
A second Huntington's gene therapy candidate advances in the regulatory pipeline amid rising interest in one-time treatments for the disease.
The agreement on a pivotal trial plan moves the company's treatment for the inherited retinal disorder toward late-stage development.
The spending reflects the industry trade group's pushback as it blames pharmacy benefit managers for high prescription costs.
With Democrats taking control of Congress, Sanders could use the PDUFA reauthorization to push reforms to how the FDA regulates companies.
The crackdown leaves rare disease families and US investors facing uncertainty as a once-booming pipeline of trials slows.
The startup targets previously undruggable cancer targets and seeks more selective treatments for autoimmune disease.
The death underscores resurgent measles transmission amid declining vaccination rates in parts of the US.
The program was halted three years ago after the first patient suffered a serious adverse event, and new developments may revive it.
The startup is developing a medicine for myeloproliferative neoplasms that an investor claims could reach beyond approved drugs in the class.
J&J and AbbVie are among companies advancing three-pronged antibodies that could mark another step forward in myeloma treatment.
The finalized policy would bar providers such as hospitals from using third parties to deliver remote monitoring services, despite broad opposition.
The administration is cutting off two groups that decide payment disputes over surprise medical bills, citing a failure to meet minimum standards.
The trial offers guidance for prescribing cholesterol medicines when statins are insufficient or not tolerated.
Democratic physicians made gains, ballot measures decided abortion, marijuana, and transgender care questions, and analysts expect biopharma to benefit.
Voter attitudes could shape legislation on AI use in medicine as more doctors consult chatbots for care decisions.
The arrival expands treatment options for rare immune disorders, though access challenges persist.
The milestone extends the company's commercial footprint for its bladder cancer therapy into Europe.
The court battle between former star scientist David Sabatini and a younger colleague continues to divide the institution.
The new venture aims to address the root cause of the hypertensive pregnancy disorder, which has few treatment options.
The candidate moves from academic research into human testing for cancer.
A closer look at the reason behind the decline examines whether the market reaction holds up to the data.
Drugmaker leaders are unconvinced by claims that AI will transform disease treatment, a gap with implications for biotech investment.
The deal expands the distributor's clinical trial supply capabilities in China.
Newly approved treatments widen the therapeutic landscape while reimbursement and access hurdles remain.
The approval adds a new treatment option for Parkinson disease, with clinicians weighing its role in practice.
Commentary and reporting weigh mRNA-based cancer vaccine progress against remaining scientific hurdles.
The annual awards recognized companies across drug discovery, immunotherapy, and oncology categories.