Hogan Lovells | USA | 14 Mar 2024
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory…
Hogan Lovells | USA | 30 Jan 2024
“Beyond Earth’s Gravity” explores the growing opportunities of pharmaceutical and biotech companies that engage in space-based drug research and…
Hogan Lovells | USA | 7 Dec 2023
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings…
Hogan Lovells | USA | 12 Oct 2023
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to…
Hogan Lovells | European Union, USA | 28 Mar 2023
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents…
Hogan Lovells | USA | 19 Jan 2023
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a…
Hogan Lovells | USA | 13 Aug 2022
Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products…
Hogan Lovells | USA | 28 Jul 2022
California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a…
Video
Hogan Lovells | USA | 13 Jul 2022
Biotech Start-Ups: Formation, Funding, and IP Licensing
Hogan Lovells | USA | 30 Jun 2022
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein…