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The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
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From Eli Lilly’s David Ricks to Pfizer’s Albert Bourla, the top five highest paid CEOs made a combined $157.8 million in 2025.
Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The best thing a professional can do when considering a position at the FDA is weigh the pros and cons. To help, we’ve created a guide to working at the FDA, with benefits, challenges and tips.
Boehringer announced that the FDA approved Spevigo for generalized pustular psoriasis flares in adults, the first drug approved for this indication.
Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.
Finch announced that it is slashing its headcount by around 37% and suspending its planned Phase I study in autism a week after Takeda withdrew from its multi-year collaboration.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
It’s been a busy week for research on rare diseases, with several clinical trials from AnaptysBio, Regenxbio, Sangamo and more posting results from ongoing activities.
A cell and gene therapy accelerator formed by Mayo Clinic, Hibiscus BioVentures and Innoforce is officially up and running, the partners announced this week.
Hard times are forcing biopharma companies to extend their runways as they try to eke out every cent of value from their capital.