fda-and-biotech News
Arrowhead Stock Surges 18% on Promising Obesity Drug Data
Company's RNAi candidate, combined with a GLP-1, nearly doubled weight loss in an early-stage trial, signaling a potential new approach in a booming market.
Sanofi Shares Fall After FDA Rejects Key MS Drug Over Liver Safety
U.S. regulator cites 'substantial and unusually high' risk of liver injury and unclear benefit for tolebrutinib, a blow to the French drugmaker's pipeline.
Stereotaxis Stock Jumps on FDA Approval for MAGiC Ablation Catheter
The approval a key milestone for the medical device firm, paving the way for its robotically navigated catheter in the competitive cardiac arrhythmia market.
Bright Minds Stock Soars on Positive Epilepsy Drug Trial Results
Phase 2 study for BMB-101 shows significant seizure reduction in drug-resistant patients, marking a key de-risking event for the biotech firm.
Kodiak Sciences Surges After ARK Invest Buys the Dip
Cathie Wood's fund adds over 53,000 shares, signaling confidence in the biotech's rebooted retinal disease drug ahead of key 2026 trial data.
Natera Stock Climbs on Positive Colorectal Cancer Trial Data
Study shows Natera's Signatera test, combined with therapy, significantly extends disease-free survival, boosting prospects for broader clinical adoption.
Galapagos to Shutter Cell Therapy Unit in Major Strategic Pivot
The move to wind down the division, acquired in 2022 for over €139M, follows a failed sale attempt, as the company pivots to conserve cash and focus on its core drug pipeline.
Gyre Therapeutics Stock Soars on Path to Chinese Drug Approval
Shares surged nearly 12% after the company announced a pivotal agreement with regulators for its liver disease drug, Hydronidone, paving the way for a faster market entry.