Shares of Corcept Therapeutics plunged 16% after a corrected FDA letter disclosed the agency had repeatedly cautioned the company against filing its application for a Cushing's syndrome drug, which was later rejected over efficacy and safety concerns.
The FDA has issued a complete response letter for Aquestive Therapeutics' sublingual epinephrine film Anaphylm, citing concerns over packaging and user instructions. The company aims to address the issues and resubmit its application by the third quarter of this year.
Cogent Biosciences secures FDA Breakthrough Therapy Designation and enters the Real-Time Oncology Review program for its lead drug candidate bezuclastinib in gastrointestinal stromal tumors (GIST), marking significant regulatory momentum for the biotech firm.
Following the FDA's decision to remove the clinical hold on Intellia's Nex-Z hATTR-PN trial, analysts at Baird and H.C. Wainwright have significantly raised their price targets for the CRISPR gene-editing pioneer, citing reduced regulatory risk and a clearer path forward.
Cogent Biosciences secures a key FDA Breakthrough Therapy Designation for its bezuclastinib-sunitinib combination in advanced GIST, following promising Phase 3 data that showed a halving of disease progression risk.
The FDA has cleared Intuitive Surgical's latest robotic system for use in certain heart surgeries, marking a strategic expansion into one of healthcare's largest and most complex service lines and potentially reshaping hospital capital planning for robotics.
Glaukos Corporation secures a significant FDA nod allowing repeated administration of its sustained-release iDose TR implant, broadening treatment options for patients with glaucoma and potentially reshaping long-term care paradigms.
Glaukos Corporation's iDose TR glaucoma therapy receives a key FDA labeling update, permitting repeat administration. While the news bolsters the company's growth narrative, analysts are divided on whether its current stock price already reflects future potential amid rich valuation metrics.
The FDA's approval of a repeat treatment protocol for Glaukos's iDose TR implant transforms it from a one-time procedure into a potential chronic therapy platform, reshaping its commercial narrative and investor calculus in the competitive glaucoma market.
The FDA's Priority Review for Vyvgart's label expansion in myasthenia gravis accelerates Argenx's growth strategy, while investors weigh the company's broader pipeline against its current valuation.
The FDA clearance of Spectrum Dynamics' Veritas.AI platform marks a significant step forward for nuclear imaging, promising to cut scan times in half and enhance image clarity for critical applications like cancer theranostics.
Exelixis has filed its next-generation therapy zanzalintinib with U.S. regulators for metastatic colorectal cancer, marking a significant step in its clinical development and potentially enhancing its competitive position in the targeted oncology space.
Fractyl Health's Revita procedure shows promise in maintaining weight after stopping GLP-1 drugs, with new six-month data prompting the company to seek a streamlined FDA pathway. A packed 2026 roadmap aims for a U.S. submission, but financial pressures loom.
The medical device developer Beta Bionics has received a warning letter from the U.S. Food and Drug Administration, a regulatory action stemming from a facility inspection last summer. The company maintains the letter will not disrupt its operations, manufacturing, or the planned launch of its new insulin patch pump.
The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.
Piper Sandler raises its price target for Century Therapeutics (IPSC), highlighting the biotech firm's robust financial position extending into 2029 and an upcoming Investigational New Drug application for its lead cell therapy candidate, CNTY-813.
Wells Fargo boosts its price target for Taysha Gene Therapies (TSHA), citing strong progress in its pivotal Rett syndrome gene therapy program. The company has dosed the first patient in a key trial phase and received FDA alignment on its regulatory pathway.
As the wearables market surges, Biolinq CEO Richard Yang positions smart patches as the next evolution, capable of tracking deep biochemical data where watches track surface metrics, with his company's FDA-cleared glucose sensor leading the charge.
The FDA has cleared Intuitive Surgical's da Vinci 5 robotic system for select complex cardiac procedures, a move that could reshape the landscape of minimally invasive heart surgery and open a significant new market for the industry leader.
Millions of sole traders and landlords face a fundamental change in how late tax submissions are penalized, as HMRC prepares to replace automatic fines with a points-based regime starting in 2026.
