Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported adverse drug events for several of its medicines. Included in the ...

For full-year 2025, 58 biotech deals worth $65.9 billion were completed compared with 73 deals worth $109 billion in all of 2024. This represents a major decline in total dollar volume and the number ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...

While pricing pressures will vary and orphan products can expect some protection now, the suggestion here is that brand planning should evaluate the merits of risk contracting for the future. At least ...

In 2025 it seemed the only certainty for biotech was more uncertainty. Biotech leaders conducted business as usual against ...

ICON Biotech surveyed 163 biotech leaders in North America, EMEA and APAC to see how they are responding to the headwinds.

Senators are probing which products fall under Medicaid-related deal provisions and whether any “MFN” prices are meaningfully lower than current Medicaid net prices after rebates.

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA ...

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA ...

FDA granted Priority Review to AstraZeneca’s supplemental application for Enhertu in early-stage HER2-positive breast cancer, moving the drug closer to a potential new indication for patients at high ...

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to ...