On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between 2020 and 2024. The FDA has described this move as a step toward the Agency’s…
To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read…
On July 3, 2025 Congress passed, and on July 4, 2025 President Trump signed into law, the One Big Beautiful Bill Act (OBBB), which extends various expiring tax provisions from the Tax Cuts and Jobs Act and introduces a variety of other substantial tax law changes. The developments highlighted below…
As part of Goodwin’s exclusive programming during the BIO International Convention in Boston, we invite you to join us for a session spotlighting the evolving world of M&A and strategic partnerships in a rapidly shifting biotech landscape. Through a dynamic fireside chat and expert panel discussions, we’ll uncover innovative deal-making…
As part of Goodwin’s exclusive programming during the BIO International Convention in Boston, we invite you to join us for a focused discussion on how biotech and pharma companies can protect and maximize the value of their intellectual property. In a time when innovation is critical and IP disputes are…
As part of our week of premier programming during the BIO International Convention in Boston, we’re bringing together industry leaders, investors, and strategic advisors for an engaging session on how European biotechs can successfully expand into the US market. This dynamic lunchtime event will dive into unlocking US capital, driving…
As part of Goodwin’s week of exclusive programming during the BIO International Convention in Boston, we’re excited to invite you to a session focused on China-based NewCos and the dynamics of cross-border dealmaking. China continues to be a dynamic hub for biotech innovation, and companies operating in this space are…
Jumpstart your week with a deep dive into the future of medicine as part of Goodwin’s exclusive programming during the BIO International Convention in Boston. Join us for a dynamic symposium where industry leaders and AI pioneers come together to unveil how artificial intelligence is revolutionizing drug discovery. Don’t miss…
While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration. The Federal Trade Commission (FTC) under new Chairman Andrew Ferguson has already launched its first merger…
On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. This latest Executive Order simultaneously pushes key stakeholders (i.e. foreign governments and drug manufacturers) to modify their current practices while threatening potential most-favored nation (MFN)-based price caps and other…