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FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
Kaiser Permanente and its affiliates have agreed to a $556 million settlement to resolve federal allegations of Medicare Advantage payment inflation through inaccurate diagnosis coding.
Kaiser Permanente and its affiliates have agreed to a $556 million settlement to resolve federal allegations of Medicare Advantage payment inflation through inaccurate diagnosis coding.
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Jazz Pharmaceuticals has sold a Priority Review Voucher for $200 million amidst uncertainty over the renewal of the voucher program in the U.S. Senate. The sale highlights ongoing challenges in the biotech regulatory landscape.
A compounding pharmacy has filed an antitrust lawsuit accusing pharmaceutical giants Eli Lilly and Novo Nordisk of engaging in anti-competitive practices in the rapidly growing weight loss drug market.
Federal data reveal a significant decline in overdose deaths across the US during most of 2025, suggesting progress against a long-term worsening epidemic.
The FDA has updated its stance on GLP-1 weight loss products by requesting the removal of suicide warnings after a detailed data review found no increased risk of suicidal ideation or behavior.
Richard Pazdur, a long-serving FDA official, recently highlighted concerns about political interference and organizational chaos that are undermining the agency's ability to effectively regulate medical products.
Top pharmaceutical companies AbbVie, Amgen, and Eli Lilly are urging the FDA to modernize its inflexible post-approval change requirements, citing these outdated regulations as key obstacles to reshoring pharmaceutical manufacturing.
Stoke Therapeutics and the FDA have not reached an agreement on an expedited submission for the company's treatment targeting severe epilepsy, impacting potential accelerated review timelines.
Four prominent scientists and administrators recently resigned from the NIH, citing concerns over lost scientific integrity and increasing interference.
Four prominent scientists and administrators recently resigned from the NIH, citing loss of scientific integrity, interference, and censorship within the organization.
New Medicaid eligibility restrictions are projected to cause over a million missed cancer screenings in two years, potentially leading to more than 100 preventable deaths, according to recent research.
