fda-and-biotech News
Recursion Pharma Shakes Up Leadership, Taps J&J Veteran as New CEO
Co-founder Chris Gibson will transition to Chairman as Najat Khan, a data science and R&D leader, takes the helm to drive the next phase of growth.
Biohaven Shares Plunge After FDA Rejects Key Neurological Drug
The U.S. regulator issued a Complete Response Letter for Vyglxia, citing issues with clinical trial data and prompting a major R&D spending cut.
Mesoblast Sets Key FDA Meeting for Opioid-Sparing Back Pain Drug
The biotech firm will meet with regulators in December to chart a path for Rexlemestrocel-L, a cell therapy that has shown promise in reducing opioid use.
Madrigal Shares Hit 52-Week High on Rezdiffra Sales Boom
The biotech firm's quarterly revenue crushed estimates, with its new liver drug generating an annualized run rate over $1 billion, overshadowing a wider-than-expected loss.
PacBio Stock Surges 75% on Landmark China Gene-Sequencing Approval
Company and partner Berry Genomics secure the first-ever regulatory clearance for a clinical long-read gene sequencer in the crucial Chinese market.
BiomX Surges After Positive FDA Feedback on Diabetic Foot Infection Therapy
Shares of the clinical-stage biotech jumped after the agency provided a clear regulatory pathway for its novel phage cocktail, BX011, targeting a multi-billion dollar market.
Merck Gains Blackstone's $700M Backing for Prostate Cancer Drug
Strategic funding from Blackstone Life Sciences will accelerate development of sacituzumab tirumotecan, a key asset in Merck's post-Keytruda pipeline.
Relmada Shares Plummet After $100M Offering Swamps Market Cap
Capital raise, larger than the biotech's entire market value, is set to fund a strategic pivot after its lead depression drug was recently discontinued.