Regulatory
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets.
The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug.
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
In this episode of Denatured, you’ll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.
Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year.
Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program.
Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
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