BioWeek

Pipeline

FDA Approves Asundexian, the First Drug Ever in a New Class of Blood Thinners

The FDA approved Bayer's asundexian, the first factor XIa inhibitor ever, cutting ischemic stroke risk by 26% on top of antiplatelet therapy with similar overall major bleeding. The class that failed in atrial fibrillation now enters the market as a stroke-recurrence drug.

10 Nov 2026 · 3 min read

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Cutting Lp(a) by 78% Did Not Reduce Heart Risk in 8,322 Patients

9 Nov 2026

Biotech Groups Sue Again to Stop Medicare's GLOBE Drug-Pricing Model

8 Nov 2026

Zolgensma's Theoretical Cancer Risk Now Has Molecular Proof

8 Nov 2026

The Race to Delete a Protein and Treat Rheumatoid Arthritis

6 Nov 2026

FDA Pushes Mitapivat's Sickle Cell Decision to February Over Liver Safety

5 Nov 2026

Ultomiris Is the Latest IgA Nephropathy Drug to Win on Proteinuria, Not Proof It Saves Kidneys

AstraZeneca's fifth Ultomiris indication arrives on a proteinuria surrogate, while the week-106 eGFR readout still decides whether the drug actually saves kidneys.

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Pipeline

Inovio's First DNA Drug Won Approval on 7 of 26 Patients Avoiding Surgery

2 Nov 2026 · 3 min read

Pipeline

Lilly's Retatrutide More Than Doubled Ozempic's Weight Loss

1 Nov 2026 · 3 min read

Pipeline

Genmab's Antibody Halves Death Risk in Head and Neck Cancer

30 Oct 2026 · 3 min read

Pipeline

Merck and Moderna's Cancer Vaccine Beat Keytruda. The Harder Test Is Manufacturing.

27 Oct 2026 · 3 min read

Markets

Bolt's Original Stockholders Own 6.9% After the Prana Reverse Merger

26 Oct 2026 · 3 min read

Markets

Gilead Is Buying Oral IL-23 Before Its Peptide Has Shown It Works

25 Oct 2026 · 3 min read

Pipeline

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Pipeline 16 Oct 2026

Verastem Bets the Frontline on a Chemotherapy-Free KRAS G12D Regimen

Verastem's 900 mg KRAS G12D dose posted a 50% confirmed response rate in second-line pancreatic cancer, and the company will take a chemotherapy-free regimen into a first-line Phase 3. The rival comparison is overall survival.

BioNTech's Cancer Vaccine Missed the Endpoint Pembrolizumab Itself Never Won

14 Oct 2026

The First Keytruda Biosimilar Filing Reaches FDA Without a Phase 3 Trial. Can Analytics Carry a $31.7 Billion Molecule?

13 Oct 2026

Rasonque's Broad Label Is Built on Survival, Not Response

11 Oct 2026

Markets

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Markets 12 Oct 2026

Viatris Just Bought Four More Years of EXPAREL Before Its Generic Cliff Arrives

Viatris is paying $1.65 billion for Pacira, roughly 2.2 times trailing revenue. The price only makes sense if you count EXPAREL's early 2030 licensed generic cliff and the four years of runway before it.

Is Claudin-1 Worth $355 Million Upfront? CSL Just Placed Its Bet

5 Oct 2026

Celcuity Ships Its First Drug Into the Corner of Breast Cancer No PI3K Label Covered

1 Oct 2026

BigHat Closes $75 Million Series C as Its AI-Designed ADC Enters the Clinic

25 Sep 2026

Policy

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Policy 15 Oct 2026

FDA Wants Its Rare Disease Flexibility Written Down. The Hard Part Is Where the Lines Land.

With only about 5% of rare conditions carrying an FDA-approved treatment, the agency is trying to turn case-by-case flexibility into written, predictable defaults. Whether that produces certainty or new rigidity is the open question.

PhRMA Sued Over a Rule That Barely Covers Anyone. The Target Is Bigger Than Drug Pricing.

8 Oct 2026

Why the FDA Overrode Its Advisers on Camizestrant

7 Sep 2026

Why uniQure's Huntington Filing Rests on Twelve Patients and Two FDA Reversals

3 Sep 2026

Science

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Science 9 Oct 2026

FDA Approves Asundexian, the First Drug Ever in a New Class of Blood Thinners

Cutting Lp(a) by 78% Did Not Reduce Heart Risk in 8,322 Patients

Biotech Groups Sue Again to Stop Medicare's GLOBE Drug-Pricing Model

Zolgensma's Theoretical Cancer Risk Now Has Molecular Proof

The Race to Delete a Protein and Treat Rheumatoid Arthritis

FDA Pushes Mitapivat's Sickle Cell Decision to February Over Liver Safety

More stories

PolyPid Nears a Potentially Transformative FDA Decision as It Advances Its Innovative Pipeline (NASDAQ: PYPD)

Lonza Is Buying the Plants Where the Hardest Drugs Get Made

Huntington's First Disease-Modifying Drug Is Now One FDA Decision Away

Ultomiris Is the Latest IgA Nephropathy Drug to Win on Proteinuria, Not Proof It Saves Kidneys

Latest

Inovio's First DNA Drug Won Approval on 7 of 26 Patients Avoiding Surgery

Lilly's Retatrutide More Than Doubled Ozempic's Weight Loss

Genmab's Antibody Halves Death Risk in Head and Neck Cancer

Merck and Moderna's Cancer Vaccine Beat Keytruda. The Harder Test Is Manufacturing.

Bolt's Original Stockholders Own 6.9% After the Prana Reverse Merger

Gilead Is Buying Oral IL-23 Before Its Peptide Has Shown It Works

Pipeline

Verastem Bets the Frontline on a Chemotherapy-Free KRAS G12D Regimen

BioNTech's Cancer Vaccine Missed the Endpoint Pembrolizumab Itself Never Won

The First Keytruda Biosimilar Filing Reaches FDA Without a Phase 3 Trial. Can Analytics Carry a $31.7 Billion Molecule?

Rasonque's Broad Label Is Built on Survival, Not Response

Markets

Viatris Just Bought Four More Years of EXPAREL Before Its Generic Cliff Arrives

Is Claudin-1 Worth $355 Million Upfront? CSL Just Placed Its Bet

Celcuity Ships Its First Drug Into the Corner of Breast Cancer No PI3K Label Covered

BigHat Closes $75 Million Series C as Its AI-Designed ADC Enters the Clinic

Policy

FDA Wants Its Rare Disease Flexibility Written Down. The Hard Part Is Where the Lines Land.

PhRMA Sued Over a Rule That Barely Covers Anyone. The Target Is Bigger Than Drug Pricing.

Why the FDA Overrode Its Advisers on Camizestrant

Why uniQure's Huntington Filing Rests on Twelve Patients and Two FDA Reversals

Science

One Transfer RNA Molecule Controls Whether Prostate Cancer Stays Treatable

Brain Shuttle Platforms Tackle the Blood-Brain Barrier for Genetic Medicines

What tumour-neuron synapses mean for glioblastoma - and why a local siRNA gel is the proposed answer

What blocking Activin A means for FOP - Regeneron’s Pasatru and a disease that turns muscle into bone