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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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Pfizer inked an Equity Subscription Agreement with France-based Valneva. They also updated their Collaboration and License deal for a Lyme disease vaccine that was announced in April.
Extension data from the Phase II TOPAZ trial showed that apitegromab yielded sustained and continued benefits in non-ambulatory patients with types 2 and 3 spinal muscular atrophy (SMA).
The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
BioSpace spoke with Janssen’s Fiona Elwood about the company’s myasthenia gravis candidate nipocalimab, which is currently recruiting for two Phase III trials.
Olema president and CEO Sean Bohen spoke with BioSpace about why he believes his company’s approach with a SERD and ER antagonist can successfully treat an advanced form of breast cancer.
An FDA advisory committee voted against Acadia Pharmaceutical’s supplemental New Drug Application of Nuplazid tablets for the treatment of Alzheimer’s-related psychosis.
Pharmaceutical giant Merck is exploring a possible purchase of biotech company Seagen, according to The Wall Street Journal.
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.