Sitemap
110 articlesA complete index of every article on this site.
Biotech
- The imaging system that watches for the surgeon's hand
- Stryker Application Asks a GAN to Draw a Wound's Future
- A Heart Valve Sized to Land Above the Ring It Replaces
- An Antibody Used as a Chassis: Regeneron Files on Tethering a GLP-1 Agonist to a GDF8 Antibody
- A Flat Catheter Tip That Both Ablates the Heart and Maps It, in One Printed Circuit
- Mapping a Blood Vessel's Flow to Decide Where a Neuromodulation Catheter Should — and Shouldn't — Fire
- What Is a CLIA Waiver? The Rule That Lets Simple Diagnostic Tests Run Almost Anywhere
- What Is a Unique Device Identifier (UDI)? The Code on Every FDA-Regulated Device
- What Is an In Vitro Diagnostic (IVD)? How the FDA Defines and Regulates Diagnostic Tests
- What Is an FDA De Novo Classification Request? The Pathway for Novel Low-Risk Devices
- FDA Medical Device Classes, Explained: How Class I, II, and III Are Defined
- What Is a Predicate Device? The Reference Point at the Heart of Every 510(k)
- 510(k) vs PMA: The Difference Between FDA Clearance and FDA Approval
- What Is an FDA 510(k) Clearance? The Premarket Notification Pathway, Explained
- Sonoma Pharmaceuticals Raises Its At-the-Market Offering Ceiling to $3.64 Million in a New 8-K
- Amgen Opens Phase 3 of Xaluritamig Plus Abiraterone in Metastatic Prostate Cancer
- Lilly's Oral GLP-1 Orforglipron Enters Phase 3 in Adolescents With Obesity
- uniQure Plans a Q3 BLA for Its Huntington's Gene Therapy After FDA Blesses Its 3-Year Data
- A Sterility-Assurance Recall Pulls 210,000-Plus Lidocaine Injection Ampules
- Metallic Particles Trigger a Class II Recall of Chewable Calcium-Carbonate Antacids, Including Tums
- A Terminated Spesolimab Extension in Hidradenitis Suppurativa, and What That Status Actually Means
- Takeda Opens a Long-Term Extension for Zasocitinib in Psoriatic Arthritis — and Safety Is the Headline Question
- Viatris Tests Cenerimod in Lupus Nephritis With Complete Renal Response as the Bar
- Biogen's Felzartamab Enters Phase 3 in IgA Nephropathy With Proteinuria as the First Test
- Filing Watch: CEL-SCI's Latest 8-K Points Back to a June 14 Prospectus Supplement
- Beamion LUNG-3 Pushes Boehringer's HER2 Pill Zongertinib Into Earlier, Curable Lung Cancer
- Moderna Points Its mRNA Platform at Multiple Sclerosis With mRNA-1195
- ACADIA's ACP-204 Targets the Hallucinations of Alzheimer's With a Three-Study Master Protocol
- Merck's KANDLELIT-004 Tests Whether a KRAS G12C Pill Plus Keytruda Beats Keytruda Alone in Lung Cancer
- Novo Nordisk's FLORAL Study Bets on the Long Game for Etavopivat in Sickle Cell Disease
- Amgen Takes Its Monthly Obesity Drug Into Sleep Apnea: Inside MARITIME-OSA-2
- Filing Read: What Lilly's 2026 10-K Actually Says About the Incretin Boom — Supply, Uptake, and Risk
- By the Numbers: Lilly's Revenue Nearly Doubled in Two Years — The Incretin Era in XBRL
- Reality Check: Moderna Is Still Spending Like a Pandemic Winner — Its Cash Balance Isn't
- Crosswalk: Who Actually Controls Casgevy? The Filings Say Vertex — and CRISPR Says So Too
- Cliff Watch: Regeneron's Own 10-K Says Eylea Faces 'Significant Competition' — Read the Risk Factor
- Anatomy of a Launch: How Vertex's Non-Opioid Pain Drug Journavx Shows Up in the Filings
- By the Numbers: Vertex's Revenue Crossed $12 Billion — The Quiet Compounding Behind the CF Franchise
- Reality Check: The Real Threat to Semaglutide Isn't Just a Rival Drug — It's Pricing, and Novo Says So
- Modality Explained: What Moderna Means When It Says 'Respiratory Vaccine Franchise'
- By the Numbers: R&D Intensity Across Lilly, Vertex, and Moderna — Who Spends Hardest to Grow
- Company Primer: CRISPR Therapeutics, as Its Own SEC Filings Describe It
- The Docket: What Six Biotech Filings, Read Together, Say About the State of the Sector
- The Docket: A Busy Week of Biotech Patent Grants Across Metabolic, Gene-Editing, and Eye Disease
- By the Numbers: CRISPR Patent Filings Are Still Climbing a Decade In
- Company Primer: What Regeneron's Patent Estate Reveals About the Eylea Fight
- Modality Explained: mRNA and the Lipid Nanoparticle That Delivers It
- What Is RNA Interference? The Quieter Cousin of mRNA Medicine, Explained
- Cliff Watch: Vertex's Cystic Fibrosis Moat Has a New Name in the Patent Record
- Modality Explained: Antibodies, Biosimilars, and Why Eye-Disease Patents Get Crowded
- Crosswalk: The Vertex and Broad Patents That Explain Casgevy's Gene-Editing Economics
- What's the Difference Between a Patent Grant and a Patent Application?
- CRISPR, Explained: What the Foundational Broad Institute Patent Actually Claims
- Reality Check: The GLP-1 Patent Story Is Crowded — and the Filings Show It
- GLP-1, Explained: How Tirzepatide Actually Works — and What Lilly Patented to Protect It
- Company Primer: Eli Lilly's Incretin Estate, Read Through Its 2025 Grants
- Reality Check: The Compounding Threat to GLP-1 Drugs Meets the Patent Record
- By the Numbers: The siRNA Patent Race Is Now a Delivery Arms Race
- By the Numbers: In 2025, the CRISPR Patent Field Stopped Being About Cas9
- Modality Explained: Beyond Cas9 — What the New CRISPR Enzymes Do Differently
- Crosswalk: Eli Lilly's 2025 Incretin Grants Read Like a Roadmap
- Crosswalk: Moderna's 2025 Grants Show the Real Asset Is the Delivery Chemistry
- Cliff Watch: Method-of-Use Patents Are the Incretin Cliff's Hidden Layer
- Modality Explained: How siRNA Drugs Switch a Gene Off
- Cliff Watch: Vertex Keeps Re-Arming the CFTR Patent Estate
- Cliff Watch: The GLP-1 Cliff Will Be Decided by Formulation, Not Just the Molecule
- Crosswalk: Novo Nordisk's Next Metabolic Bet, in Its Own Patents
- By the Numbers: Prime-Editing Filings Grew Up in 2024
- Reality Check: Bispecific Antibodies Are Powerful — and Dangerous by Design
- Modality Explained: Bispecific Antibodies, the Molecule With Two Hands
- Modality Explained: Prime Editing, the 'Search-and-Replace' for DNA
- Modality Explained: The 'Fetal Hemoglobin Switch' That Gene Therapies Flip
- Reality Check: The GLP-1 Gold Rush Has a Crowded, Mostly Anonymous Patent Map
- By the Numbers: Antibody-Drug Conjugate Filings Hit a Different Gear in 2023
- Modality Explained: Antibody-Drug Conjugates, the 'Guided Missile' of Cancer Therapy
- Reality Check: The Hard Economics Behind 'Miracle' Gene Therapies
- Modality Explained: How a Hollowed-Out Virus Delivers a Gene Therapy
- Crosswalk: How a CRISPR Sickle-Cell Fix Shows Up in the Patent Record
- Modality Explained: What a 'Co-Agonist' Peptide Really Is
- Reality Check: A Triple Agonist Is Easy to Patent and Hard to Prove
- By the Numbers: In 2022, CRISPR Patents Shifted From Tools to Therapies
- Crosswalk: Why a 2022 Broad Institute Grant Still Mattered to the Whole Field
- Modality Explained: Why the New Obesity Drugs Hit More Than One Receptor
- By the Numbers: The mRNA Filing Surge Was Never Only About Vaccines
- Company Primer: How Genentech Engineers an Anti-VEGF Antibody, Patent by Patent
- Crosswalk: Why mRNA Manufacturing Is the Quiet Moat
- Crosswalk: Why an Eye Drug Would Block Two Signals Instead of One
- Reality Check: The mRNA 'Platform' Was Always Bigger Than the Vaccine
- Modality Explained: Why an mRNA Vaccine Needs a Fatty Bubble to Work
- Crosswalk: How an Anti-VEGF Eye-Disease Patent Thicket Gets Built
- By the Numbers: Where the GLP-1 Patent Map Pointed in 2020
- Modality Explained: What an 'Endonuclease' Actually Does
- Modality Explained: What 'RNA-Guided' Gene Editing Actually Means
- Risk Factor Read: In 2020, Lilly's Tirzepatide Was Still Just a Phase III Bet
- Modality Explained: What CRISPR Therapeutics Was Actually Building in 2020
- Filing Read: What Moderna's 2020 Annual Report Says Lies Beyond the COVID Vaccine
- Risk Factor Read: “Submitted” Is Not “Approved” — Reading Lilly's 2021 Tirzepatide Status
- Modality Explained: How an mRNA Medicine Actually Works, Per Moderna's 2021 10-K
- Crosswalk: Who Pays and Who Profits on Exa-cel, Per the 2022 Filings
- Filing Read: The 50/50 Split Behind the First CRISPR Medicine
- Cliff Watch: Regeneron's Own 10-K Says It Depends on Eylea
- Cliff Watch: Regeneron Says Even Eylea HD Faces “Significant Competition”
- Filing Read: What Actually Powers Vertex's Cystic Fibrosis Franchise
- By the Numbers: How to Read Novo Nordisk's 2024 Annual Filing (It's a 20-F)
- Reality Check: Regeneron's Eylea Transition Is Still a Risk, Per Its Latest Filing