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Sept. 10, 2025
| This week’s commercialization news and insights for biopharma leaders
J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.
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The companies said their updated shot spurred an increase in neutralizing antibodies against currently circulating strains, answering calls for more corroborating evidence.
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The drugmaker’s new CEO said the moves will help the company be more agile as it deals with competition in the obesity market and a declining stock price.
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Despite its "high-risk" reputation, neuroscience attracted over $1.5B in venture funding last year while delivering breakthrough treatments for Alzheimer's & ALS. Explore the latest developments in the field in
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The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect fewer than 1,000 people in the U.S.
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News roundup
The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.
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UPDATED
Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.
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