FDA approval
The latest news about FDA approval: headlines, AI summaries and the full story from every source.
- Capricor Therapeutics Shares Rise Following JonesTrading Upgrade Ahead of FDA Decision
- FDA Approves Pimjetmi for Tenosynovial Giant Cell Tumor
- Freenome Reports Q3 Earnings Beat Driven by Collaboration Revenue
- Scholar Rock Reports Q3 2026 Results Following ISEMBYLD FDA Approval
- Scholar Rock Anticipates CHMP Opinion in 2027 Following ISEMBYLD FDA Approval
- FDA Approves Bayer's Asundexian for Secondary Stroke Prevention
- Royalty Pharma Poised to Benefit from Revolution Medicines' FDA-Approved Pancreatic Cancer Drug
- Johnson & Johnson Announces Positive Late-Stage Trial Results for Psoriatic Arthritis Treatment
- Vera Therapeutics Targets 50% Patient Coverage by Year-End Following TRUTAKNA Launch
- Novo Nordisk CEO Provides Timeline for CagriSema Obesity Drug Launch
- Revolution Medicines Reaffirms 2026 GAAP Operating Expense Guidance Following RASONQUE FDA Approval
- Viatris Announces Quarterly Dividend of $0.12 Per Share
- Ultragenyx Outlines 2027 Profitability Strategy Following Pipeline Adjustments
- Denali Therapeutics Projects $30M-$32M Q4 Revenue for AVLAYAH Amid Hunter Syndrome Commercialization
- Danaher Subsidiary Cepheid Receives FDA Approval for Xpert Hemorrhagic Fever Panel
- Dr. Reddy's Laboratories Receives FDA Tentative Approval for Generic Version of Gilead's Yeztugo
- Precigen Shares Drop 25% Following Inovio's FDA Approval of Voceryq
- Inovio Pharmaceuticals Shares Surge Following FDA Approval of Voceryq for RRP
- NRx Pharmaceuticals Receives FDA Approval for Generic Ketamine Injection
- Axsome Therapeutics Shows Consistent Revenue Growth Amidst Moderna's Volatility
- Amgen vs. Vertex Pharmaceuticals: A Comparison of Revenue Scale and Growth Trajectories
- FDA Approves Pfizer's Talzenna and Xtandi Combination for Metastatic Hormone-Sensitive Prostate Cancer
- Bristol Myers Squibb and Novo Nordisk Comparative Revenue Analysis
- Revenue Comparison: Eli Lilly's GLP-1 Growth vs. Bristol Myers Squibb's Steady Performance
- FDA Approves Oral Pellet Formulation of BioCryst's Orladeyo
- Moderna's mRNA Pipeline Expansion Drives Growth Potential Beyond COVID-19 Vaccines
- Roivant Sciences Shares Rise Following Positive Late-Stage Trial Results for Lisraya
- ALS Association Launches Campaign Against Insurance Denials
- Mesoblast Reports GAAP EPS of -$0.04 and Revenue of $120.25M in Q4
- Axsome Therapeutics Expands Auvelity into Alzheimer's Market with Strong Early Sales
- Ultragenyx to Sell FDA Priority Review Voucher for $210 Million
- Celcuity Stock Rises on Launch of First Commercial Product
- Abbott Launches SimpleScreen Blood Test for Colorectal Cancer Screening
- Staar Surgical Shares Rise Nearly 8% After Analyst Upgrade
- Nyxoah Appoints Liam Kelly as New CEO
- BridgeBio's Attruby Outperforms Pfizer’s Vyndamax in Real-World Study
- Merck Stock Surges Despite Stable Revenue Growth
- Telix Pharmaceuticals Rises for Second Day After FDA Approval of Pixclara
- Johnson & Johnson Launches Surgical Robot Ottava in Competitive Robotic Surgery Market
- Institutional Investors Are Increasing Their Stake in Madrigal Pharmaceuticals
- BioXcel Therapeutics Files for Bankruptcy Just Weeks Before Key FDA Decision
- Royalty Pharma Acquires $100M Stake in Rusfertide for Polycythemia Vera
- PMV Pharmaceuticals Raises $50.8 Million to Support Ovarian Cancer Drug Development
- Teva Pharmaceuticals Acquires Neuroscience Assets from BioXcel Therapeutics in Up to $125M Deal
- Atrium Therapeutics Receives $15 Million Milestone Payment from Bristol-Myers Squibb
- FDA approves first broad RAS-targeted drug for metastatic pancreatic cancer
- Stanley Druckenmiller Invests in Revolution Medicines Amid Strong Clinical Results
- Dexcom Adjusts Full-Year Revenue Outlook Following 13% Growth in Second Quarter
- Eli Lilly's Stock Surge Was Predictable Based on Publicly Available Information
- Premarket Stock Movements: Replimune Surges Over 130%, Amazon Rises More Than 11%