FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
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 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.
READ MORE
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.
Recent controversies surrounding the FDA, including the refusal to review Moderna's mRNA flu vaccine, have escalated tensions to the highest levels of government, bringing scrutiny on FDA Commissioner Marty Makary and vaccine policy leadership.
Under the leadership of newly appointed FDA CDER chief Tracy Beth Høeg, safety inquiries have been initiated regarding the use of antidepressants during pregnancy and respiratory syncytial virus (RSV) antibodies in infants, signaling a renewed focus on drug safety evaluation at the agency.
