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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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BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
Novartis and Medicines for Malaria Venture are moving into Phase III for a combination treatment targeting the rise of artemisinin-resistant Malaria infection.
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”).
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.
Merck is eyeing another major label expansion for its flagship anti-PD-1 therapy Keytruda following an interim analysis of KEYNOTE-859 trial.
The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.
Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.
In a volatile year, marked with challenges, BioSpace is taking a pause to reflect on the many “wins” in biopharma.
Lysogene’s investigational gene therapy LYS-SAF302 failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.