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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’s approval of Amylyx’s Relyvrio has ignited the growing momentum in the ALS space. BioSpace spoke with Amylyx co-CEOs Justin Klee and Josh Cohen and leading ALS researcher Dr. Merit Cudkowicz.
Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.
In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.
The HHS Office of Inspector General found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued Thursday.
As it gears up to launch several new products, Moderna has created a new leadership role and onboarded an industry veteran.
Solid Biosciences and AavantiBio – announced Friday they are merging to develop a portfolio of neuromuscular and cardiac programs, initially focusing on Duchenne muscular dystrophy.
Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.