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In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Read More
Medicare coverage of anti-obesity medications (AOM) — now CMS approved for cardiac patients — could drive up the federal deficit over the next decade, according to a new report issued by the Congressional Budget Office (CBO). Read More
The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing new drugs, effectively trimming six months of protection from the current eight years for some products. Read More
An FDA proposed rule will establish criteria the agency will use to create two lists — drug products and categories of drug products — that present demonstrable difficulties for compounding (DDC Lists) and identify three categories of drug products on both DDC Lists. Read More
Although less enthusiastic about Bristol Myers Squibb’s Abecma, the committee agreed by a vote of 8-3 that its benefit outweighed its risks in treating multiple myeloma. Read More
AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Read More
Recommendations for drug sponsors to assess the impact of impaired renal function on pharmacokinetics (PK) and/or pharmacodynamics (PD) of an investigational drug, how to determine the recommended dosage, and how to provide appropriate labeling are the subjects of a recently released FDA final guidance. Read More
Lenmeldy (atidarsagene autotemcel) manufacturer Orchard Therapeutics received approval from the FDA as the first gene therapy indicated for the treatment of children with pre-symptomatic late infantile/early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More