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The FDA has denied an approval for Summit Therapeutics’ ivonescimab to treat EGFR-mutated non-small cell lung cancer, blocking the drug’s entry to the U.S. after it became available in China in 2024.
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BioSpace reviews upcoming cardiovascular milestones after a summer of missed targets.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
To grow into a biopharma juggernaut, China aims to become the leading source of innovative medicines on the global markets—a goal that experts say the country is on track to hit.
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Read our takes on the biggest stories happening in the industry.
Watching the baseball playoffs this week, I was struck by the parallels between the Los Angeles Dodgers and Eli Lilly. Both franchises spend a lot of money and always appear to come out on top.
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Windward Bio’s public debut brings this year’s IPO count well above the sluggish total of eight in 2025.
Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027.
ObesityWeek 2026, which kicks off on Saturday, will spotlight presentations on the ascendant amylin pathway, as well as therapies looking to improve the quality of weight loss and patients’ persistence on treatment.
Addex Therapeutics spinout Neurosterix will use the series B funds to advance an oral drug targeting M4, a muscarinic receptor also targeted by BMS’ Cobenfy, which introduced a new mechanism for treating schizophrenia with its 2024 approval.
In advance of a Senate vote on Heidi Overton as the next FDA commissioner, the agency has shelved the Commissioner’s National Priority Voucher program introduced by former leader Marty Makary, Reuters reported Thursday.
With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval.
Bristol Myers Squibb is combining all research and development efforts under one leader as pressure rises to replenish its pipeline.
In this episode of Denatured, you’ll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora. We explore why drug shortages are getting worse, and how combining predictive supply-chain analytics with agile, distributed manufacturing could finally make essential medicines more resilient and accessible.
Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters.
Mean splicing correction for PepGen’s PGN-EDODM1 was 46.5% at week 13, compared to under 30% for competitors like Dyne Therapeutics, Novartis and Ionis Pharmaceuticals.