Latest Biotech News

Roivant’s brepocitinib (Lisraya), developed for dermatomyositis, cleared the FDA hurdle in an approval that establishes a new oral option for a disease long managed primarily with high-dose...

AstraZeneca and Amgen said Tezspire (tezepelumab) hit the coprimary endpoints and key secondary endpoints in a Phase 3 study of eosinophilic esophagitis (EoE) in the Crossing trial. The result...

AusperBio secured $120 million in a Series C to advance an oligonucleotide therapy for chronic hepatitis B through later-stage development. The funding is intended to push an HBV-directed program...

CytomX won FDA Fast Track designation for varsetatug masetecan (CX-2051), an EpCAM-directed masked ADC for relapsed or refractory metastatic colorectal cancer. The agency’s action follows phase 1...

DualityBio and Genentech agreed to a collaboration and license deal centered on DUPAC, DualityBio’s next-generation ADC payload platform aimed at overcoming resistance seen with topoisomerase...

Biopharma M&A activity stayed strong through July 2026, with total deal value for the first seven months reaching $186.69 billion—13% higher than the comparable period in 2025. The update...

Researchers reported technical advances in prime editing that support more precise insertion of larger DNA fragments. The work describes donor-complementary prime editing enabling kilobase-scale...

Abbott received CE mark approval for Amulet 360, its next-generation left atrial appendage occluder designed for patients with non-valvular atrial fibrillation at risk of stroke. The clearance...

Checkpoint blockade can trigger the first wave of tumor rejection even when a key dendritic cell subset (cDC1) is missing, according to a study from Hokkaido University and collaborators. The...

The FDA approved Roivant/Priovant’s oral JAK1/TYK2 inhibitor brepocitinib (Lisraya) for dermatomyositis, giving the company its first regulatory win in a rare autoimmune indication. The approval...

The FDA approved Eli Lilly’s tirzepatide (Mounjaro) to reduce cardiovascular risk in adults with type 2 diabetes at high risk for events. The approval is based on SURPASS-CVOT, a head-to-head...

Researchers reported early clinical signals that CAR-T therapy can induce meaningful remission in treatment-refractory, seropositive rheumatoid arthritis. In the COMPARE phase 1 study at...

Roche won expanded FDA clearance tied to Jazz Pharmaceuticals’ HER2-directed therapy Ziihera, extending test eligibility for first-line HER2-positive stomach cancer patients. The update covers use...

DualityBio and Genentech inked a major collaboration to develop antibody-drug conjugates built around DualityBio’s DUPAC payload platform. The deal includes $45 million upfront with potential...

Biocentury reported that mid-sized biotech companies are being pressured to accept MFN pricing deals modeled for big pharma, with the core consideration centering on payer mix and tariff exposure....

The FDA alerted that Abiomed is removing Automated Impella Controllers after reports of serious injuries and deaths tied to purge cassette recognition issues. The notice points to a safety defect...

CRISPR Therapeutics reiterated its plan to pursue the highest dose for its lipid-lowering gene editing therapy, citing mixed durability results a year after dosing in early-stage data presented at...

A functional genomics study mapped broad, convergent asciminib resistance mechanisms in BCR::ABL1 chronic myeloid leukemia. Researchers identified 279 resistance mutations, including changes...

BioNTech’s predecessor Phase 2 personalized mRNA cancer vaccine program was terminated, underlining execution risk in a crowded personalized oncology vaccine field. The cancellation came just a...

Eli Lilly’s tirzepatide, branded as Mounjaro, won FDA approval to reduce cardiovascular risk in adults with type 2 diabetes at high risk for heart attack, stroke or cardiovascular death. The...