News

Caribou is halting vispa-cel and CB-011, allogeneic CAR-T therapies that showed up to 92% response rates, citing a difficult financing environment.

Celltrion USA's Omlyclo, the first interchangeable biosimilar to Xolair, reaches the U.S. market across four allergic and inflammatory indications.

Alvotech turns to a CDMO's 40,000-liter Syracuse facility for biosimilar drug substance as it expands its manufacturing network.

AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.

New data and partnerships are advancing brain-penetrant enzyme therapy, targeted antibodies, flexible obesity dosing, and frontline lymphoma treatment strategies.

Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.

Part 2 of the VK2735 maintenance study tests whether daily or weekly oral tablets can hold weight loss first achieved with weekly subcutaneous injections.

CSL and Alentis will co-develop lixudebart, an antibody targeting claudin-1, across 3 rare kidney and liver disease indications.

AL050 aims to treat GBA1-driven Parkinson disease by delivering a GCase enzyme across the blood-brain barrier.

Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.

The glucagon/GLP-1 dual agonist hit both weight loss endpoints in phase 3, though gastrointestinal discontinuations and competitor data temper the readout.

CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.

Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.

The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.

A planned phase 3 trial will test the TROP2 ADC and PD-1/VEGF bispecific together in 1st-line triple-negative breast cancer.

Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).

Real-world data show weight loss after switching to the Wegovy pill, Lilly reports positive hand and foot atopic dermatitis data, and Teva wins FDA approval for a Xgeva biosimilar.

In the OCTANE real-world analysis presented at EASD 2026, adults who switched from injectable semaglutide or tirzepatide to once-daily oral semaglutide lost an average of 4.1% of body weight after 3 months.

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.

Meeta Gulyani, Ecolab Life Sciences, shares where biomanufacturing is headed next and why the relationship between drug developers and their suppliers is changing along with it.