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Original reporting and analysis on the stories shaping biotech.

The FDA Just Wrote a Rulebook for Tripping

Clinical & Regulatory6 min read

The FDA Just Wrote a Rulebook for Tripping

The FDA just finalized its guidance for psychedelic clinical trials, covering everything from psilocybin study design to how many monitors need to be in the room during a dosing session. It's the clearest regulatory roadmap the field has ever had, and it could put the first approved psychedelic on the market by early 2027.

Jul 15, 2026Read article

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An Ebola Pill Gets Its First Real Test in the Middle of an Outbreak

Clinical & Regulatory5 min read

An Ebola Pill Gets Its First Real Test in the Middle of an Outbreak

Congo just started testing Gilead's oral antiviral obeldesivir as post-exposure prevention during an active Bundibugyo Ebola outbreak that has killed over 700 people. With no approved treatments for this Ebola species, the trial could reshape how the world fights outbreaks.

The $2.5 Billion Handshake That Could Rewrite How Drugs Get Made

Deals & M&A4 min read

The $2.5 Billion Handshake That Could Rewrite How Drugs Get Made

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Insilico Medicine and Bora Pharmaceuticals just announced a potential $2.5 billion AI alliance, but it's not about discovering drugs. It's about completely rethinking how they're manufactured. Welcome to AI's next frontier in pharma.

Jul 15, 2026

Biogen's Alzheimer's Drug Failed Its Test. They're Betting Billions Anyway.

Clinical & Regulatory4 min read

Biogen's Alzheimer's Drug Failed Its Test. They're Betting Billions Anyway.

Biogen's anti-tau Alzheimer's drug missed its primary endpoint but delivered "unprecedented" tau reduction and meaningful cognitive benefits at the lowest dose. Now they're betting on a Phase 3 trial that could reshape the entire field.

The $10 Million Drug That Just Turned Celcuity Into a $5 Billion Company

Clinical & Regulatory4 min read

The $10 Million Drug That Just Turned Celcuity Into a $5 Billion Company

A Minnesota diagnostics company bought a shelved Pfizer drug for $10 million in 2021. Five years later, it just got FDA approval for breast cancer, the stock is up 700%, and Big Pharma might come calling.

The Bet to Dethrone Immunology's Biggest Cash Cow

Funding & Financings5 min read

The Bet to Dethrone Immunology's Biggest Cash Cow

A three-year-old biotech just filed to go public with plans to take on Dupixent, immunology's $18 billion juggernaut. Attovia Therapeutics has $255 million in venture backing, miniaturized antibodies, and a very long road ahead.

The FDA Wants to Build Drug Factories Inside Hospitals

Clinical & Regulatory5 min read

The FDA Wants to Build Drug Factories Inside Hospitals

The FDA proposed a new rule that could let drug manufacturers register entire networks of modular production units as a single facility. For cell and gene therapies, it's the regulatory foundation for a future where your cancer treatment gets made down the hall, not across the country.

The Hair-Loss Drug That Just Made Investors 60% Richer Overnight

Clinical & Regulatory4 min read

The Hair-Loss Drug That Just Made Investors 60% Richer Overnight

Q32 Bio's stock surged 60% after its hair-loss drug posted dramatically better results at 36 weeks than it did at 24. The secret weapon isn't raw efficacy; it's a safety and durability profile that could reshape the $4 billion alopecia market.

The FDA Went Silent for Three Months. Then 14 Rejection Letters Dropped at Once.

Clinical & Regulatory5 min read

The FDA Went Silent for Three Months. Then 14 Rejection Letters Dropped at Once.

The FDA went dark on drug rejection letters for three months after a pharma company challenged its transparency policy. Then 14 of them appeared on the public database at once, raising urgent questions about the future of regulatory disclosure in biotech.

The Cancer Drug That Made Tumors Vanish in Every Single Patient

Clinical & Regulatory5 min read

The Cancer Drug That Made Tumors Vanish in Every Single Patient

GSK's Jemperli just hit its primary endpoint in a rectal cancer trial, building on a streak where every single patient's tumor vanished without surgery. The implications for how we treat cancer are bigger than one drug.

Roche Just Beat Both Rivals in the Biggest KRAS Showdown Yet

Clinical & Regulatory4 min read

Roche Just Beat Both Rivals in the Biggest KRAS Showdown Yet

Roche's divarasib just beat both Amgen's sotorasib and BMS's adagrasib head-to-head in a Phase 3 lung cancer trial, hitting survival endpoints that could reshape KRAS G12C treatment. Wall Street is cautiously optimistic, but the real prize is still up for grabs.

Ebola Has No Vaccine. Oxford Just Changed That.

Clinical & Regulatory5 min read

Ebola Has No Vaccine. Oxford Just Changed That.

Congo's Ebola outbreak just spread to two new provinces, and here's the problem: the approved vaccines don't work against this strain. Oxford is racing to change that with the first-ever human trial of a Bundibugyo-specific vaccine, built on the same platform as the AstraZeneca COVID shot.

Big Pharma Can't Stop Shopping in China

Deals & M&A4 min read

Big Pharma Can't Stop Shopping in China

Chinese biotech companies inked $110 billion in out-licensing deals in just six months, a record that puts 2026 on pace to demolish last year's total. Every major Western pharma company is now shopping in China, and the carts keep getting bigger.

The Alzheimer's Drug That Just Escaped the Waiting Room

Clinical & Regulatory6 min read

The Alzheimer's Drug That Just Escaped the Waiting Room

The FDA just approved an at-home starting dose for Leqembi, letting Alzheimer's patients skip the infusion center entirely. It's not just a convenience upgrade; it could unclog the biggest bottleneck holding back the first drug to actually slow the disease.

J&J Just Lost 43% of Stelara Revenue. Why Is Wall Street Cheering?

Deals & M&A4 min read

J&J Just Lost 43% of Stelara Revenue. Why Is Wall Street Cheering?

J&J's blockbuster immunology drug Stelara saw its Q2 revenue plunge 43% as biosimilar copycats flooded the market. But somehow the company posted record pharma sales and sent the stock soaring. Here's how they pulled it off.

The AI That Picks Which Cancer Patients Will Actually Survive

Science & Discovery4 min read

The AI That Picks Which Cancer Patients Will Actually Survive

AstraZeneca and Tempus AI built an AI framework that retroactively improved survival in cancer trials by 15%, not by changing the drug, but by picking better patients. The real test: can it work prospectively?

CRISPR's First Cure Has a Problem Nobody Saw Coming

Clinical & Regulatory4 min read

CRISPR's First Cure Has a Problem Nobody Saw Coming

Casgevy, one of the first CRISPR therapies ever approved, can essentially cure sickle cell disease. But a bizarre bottleneck at the very first step of treatment is preventing most patients from ever getting it. Only about 60 people have been treated in over two years.

The 2-Year-Old Who Could Be Cured Before Kindergarten

Clinical & Regulatory4 min read

The 2-Year-Old Who Could Be Cured Before Kindergarten

The FDA just approved a CRISPR gene therapy for sickle cell patients as young as two years old, potentially offering a cure before the disease can cause lasting damage. But the $2.2 million price tag and chemo conditioning raise questions about who actually gets access.

The FDA Just Overruled Its Own Experts on Moderna's Flu Shot

Clinical & Regulatory5 min read

The FDA Just Overruled Its Own Experts on Moderna's Flu Shot

The FDA's vaccine advisory panel voted 9-0 that Moderna's mRNA flu shot was safe and effective. Then the agency rejected it anyway, on trial design grounds that blindsided the industry. The fallout could reshape how vaccine makers think about U.S. development for years.

The FDA Just Made It Easier to Build a Drug for One Patient

Clinical & Regulatory4 min read

The FDA Just Made It Easier to Build a Drug for One Patient

The FDA just unveiled a new framework that lets gene therapies win approval based on biological plausibility rather than massive clinical trials, and ARPA-H is backing it with $160 million. For the 95% of rare diseases with zero approved treatments, this could change everything.

What If You Could Kill Cancer Before It Even Starts?

Science & Discovery4 min read

What If You Could Kill Cancer Before It Even Starts?

A tiny trial at Dana-Farber gave CAR-T therapy to patients who didn't have cancer yet, just a high-risk precursor condition. Every single patient responded, and the results could rewrite the rules of when we fight cancer.

Bladder Cancer's Chemo Monopoly Just Got Broken

Clinical & Regulatory6 min read

Bladder Cancer's Chemo Monopoly Just Got Broken

The FDA just cleared Keytruda plus Padcev for muscle-invasive bladder cancer with no cisplatin requirement, filling a gap that left nearly half of patients without effective perioperative therapy. The clinical data is striking: 57% of patients had zero detectable cancer at surgery.