FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
Several 'most-favored nation' drug pricing agreements forged under the Trump administration are ending after three years, creating uncertainty, while the 340B drug discount program continues to spark controversy across the U.S.
Several 'most-favored nation' drug pricing agreements forged under the Trump administration are ending after three years, creating uncertainty, while the 340B drug discount program continues to spark controversy across the U.S.
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The FDA's docket this March includes postponed decisions on treatments for a rare form of obesity and dry eye disease, underscoring ongoing challenges in drug approval timelines.
The recent settlement between Henrietta Lacks’ estate and Novartis highlights ongoing issues around consent and racial justice in biomedical research related to the historic HeLa cell line.
The CDC has added two new members to its Vaccine Advisory Committee (ACIP) as part of ongoing efforts to enhance guidance on immunization policies amidst a complex healthcare environment.
Pharmaceutical companies face increasing legal uncertainty as multiple states challenge the CDC’s revised vaccine schedule, impacting sales and regulatory strategies for major vaccine makers.
CBER Director Vinay Prasad is under investigation for allegations concerning a toxic workplace environment, raising concerns about leadership and organizational culture at the FDA.
Boehringer Ingelheim’s drug Hernexeos received an accelerated first-line approval for HER2-positive non-small cell lung cancer, leveraging an FDA pilot program designed for products of national interest.
This article explores ongoing turmoil within the FDA, the impact of upcoming elections on health regulation, and the growing role of artificial intelligence in drug discovery and healthcare.
Regulators face the complex challenge of balancing safety and access in rare disease treatments, as highlighted by the case of Sarepta Therapeutics’ Elevidys.
Following an earlier rejection for a jet lag indication, Vanda Pharmaceuticals has obtained FDA approval for Bysanti, a drug for treating bipolar disorder and schizophrenia.
Nature Medicine has launched an investigation after discovering inconsistencies in a study suggesting that cancer immunotherapy is more effective when administered in the morning.
