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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
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Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Regeneron Pharmaceuticals announced intentions to acquire Sanofi’s stake in a drug they developed together, Libtayo (cemiplimab).
In partnership with the U.S. government, Evonik Industries is investing more than $200 million to build a lipid manufacturing facility in the United States.
Children under the age of five could be eligible to receive Pfizer-BioNTech’s vaccine against COVID-19 as soon as late June.
Cassava Sciences is reeling after another journal retracted an article co-authored by a key collaborator on its experimental Alzheimer’s disease therapeutic, simufilam.
Repare Therapeutics announced a global cancer collaboration valued at up to $1.2 billion with Swiss pharma giant Roche for the development and commercialization of camonsertib.
Upstream Bio is focusing its efforts on an experimental treatment for severe asthma licensed from Astellas Pharma.
Most money moves happened in Europe this week, including a government-backed award for Parkinson’s disease research and seed funding for an RNA platform.
Seattle-based Sana Biotechnology is moving on from its current Fremont, California manufacturing facility, inking a lease deal to develop a manufacturing plant in Bothell, Washington.
AstraZeneca CEO Pascal Soriot has been knighted in the Queen’s Birthday Honours for his contribution to life sciences and leadership during the COVID-19 pandemic.
Transition Bio has a four-component platform called Condensomics which provides a technological method to understand the properties of condensates.