fda-and-biotech News
Vera Therapeutics Files for Atacicept Approval in Key Kidney Disease
Company seeks accelerated FDA approval for its IgA nephropathy drug, but shares dip in a potential 'sell the news' reaction amid a competitive landscape.
Ardelyx Posts Strong XPHOZAH Real-World Data at Kidney Week
New studies demonstrate significant phosphate reduction and high patient satisfaction, bolstering the case for its novel kidney disease drug.
Eledon Shares Plummet 55% on Mixed Kidney Transplant Trial Results
The biotech's lead drug, tegoprubart, missed its primary goal in a mid-stage study, erasing over $250 million in market value despite the company's plan to advance.
Lilly Shares Fall as Pricing Deal Overshadows Obesity Drug Trial Success
The drugmaker's stock dropped over 3% after the White House announced a deal to lower GLP-1 drug costs, eclipsing positive Phase 2 data for its new oral treatment, eloralintide.
Gilead Shares Fall After Key Cancer Drug Trial Misses Primary Goal
Trodelvy failed to meet its progression-free survival endpoint in a Phase 3 breast cancer study, overshadowing a potential positive trend in overall survival.
Gilead Shares Rise on Strong Long-Term Liver Drug Data
New three-year results for Livdelzi show sustained efficacy in treating rare liver disease, reinforcing the drug's potential ahead of a key FDA decision.
FDA Fast-Tracks Obesity Drugs from Lilly, Novo Nordisk
Pharma giants receive priority review vouchers for blockbuster weight-loss and cancer drugs in a deal linked to significant price concessions with the White House.
Soleno Stock Plummets 30% as VYKAT XR Launch Concerns Eclipse Record Quarter
Shares hit 52-week lows after management revealed a slowdown in patient starts and rising discontinuations for its key Prader-Willi syndrome drug, sparking legal scrutiny.