News

The approval of zenocutuzumab-zbco for NRG1 fusion-positive cholangiocarcinoma expands precision oncology options for patients with rare molecularly defined cancers.

Zai Lab received FDA Fast Track designation for zocilurtatug pelitecan, a DLL3-targeting antibody-drug conjugate, advancing development of a potential new treatment option for extrapulmonary neuroendocrine carcinomas.

argenx secured expanded FDA approval for efgartigimod alfa-fcab and efgartigimod alfa and hyaluronidase-qvfc broadening access to all adult patients with generalized myasthenia gravis regardless of antibody status.

Today’s BioPharm Brief covers next-generation immunotherapy, scalable peptide manufacturing, and Johnson & Johnson’s dual-pathway approach to inflammatory bowel disease treatment.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Harbour BioMed has received FDA IND clearance to begin a Phase I trial of its B7H4xCD3 bispecific antibody HBM7004 for advanced solid tumors, advancing its pipeline of T cell–engaging cancer immunotherapies.

Johnson & Johnson reported Phase 2b results for its investigational dual-pathway co-antibody JNJ-4804, showing improved clinical remission and endoscopic outcomes in patients with refractory inflammatory bowel disease.

FDA’s extended review of a subcutaneous formulation of lecanemab highlights ongoing regulatory evaluation of alternative anti-amyloid delivery approaches for early Alzheimer’s disease.

Merck scientists have published a new large-scale biocatalytic manufacturing approach for enlicitide decanoate, an investigational oral PCSK9 inhibitor, potentially advancing scalable production of macrocyclic peptide therapeutics for cardiovascular disease.

Hypoimmune cell engineering may enable scalable type 1 diabetes therapies without immunosuppression, advancing regenerative medicine approaches, according to Dr. Steve Harr, president and CEO of Sana Biotechnology.

Aptevo Therapeutics reported updated Phase 1b data from its RAINIER AML study showing high remission and clinical benefit rates for mipletamig in combination with venetoclax and azacitidine in frontline acute myeloid leukemia patients.

Entrada Therapeutics reported positive topline Phase 1/2 data for ENTR-601-44 in Duchenne muscular dystrophy, showing favorable safety, increased dystrophin production, and statistically significant functional improvement in treated patients.

Kanvas Biosciences and LTZ Therapeutics raised a combined $86 million to advance novel cancer immunotherapy platforms targeting the microbiome and innate immune system, respectively.

GSK’s licensing agreement for SiranBio’s ALK7-targeting siRNA candidate expands development efforts aimed at reducing cardiometabolic risk in chronic inflammatory diseases.

Biopharma news today highlights precision MASH therapies, emerging immuno-oncology platforms, and major U.S. manufacturing investments reshaping drug development and supply chains.

Amgen and Eli Lilly and Company are expanding U.S. pharmaceutical manufacturing with multibillion-dollar investments aimed at strengthening domestic supply chains and supporting advanced therapies. The moves reflect a broader industry shift toward biologics scale-up, genetic medicine capabilities, and more resilient production infrastructure.

LTZ Therapeutics’ $38 million financing supports phase 1 development of myeloid engager therapies targeting oncology and autoimmune diseases.

Madrigal licensed Arrowhead's ARO-PNPLA3 to target PNPLA3 I148M-associated metabolic dysfunction–associated steatohepatitis, expanding options beyond approved resmetirom.

Phase III data in thyroid eye disease, long-term ulcerative colitis outcomes, and Crohn disease advances highlight continued momentum in biologics and immunology innovation.

New long-term data reported by Eli Lilly and Company show Omvoh achieved sustained disease clearance through four years in ulcerative colitis, highlighting the potential durability of interleukin-23–targeted therapies.

Data from a phase 3 study show statistically significant improvements in proptosis and diplopia, along with favorable tolerability, which support regulatory advancement of elegrobart, a subcutaneous IGF-1R–targeting therapy for chronic autoimmune disease.

Phase 3 FUZION data showed guselkumab improved fistula remission vs placebo in adults with perianal fistulizing Crohn disease.

FDA approvals, biotech acquisitions, and clinical trial updates are shaping today’s biopharma landscape. This episode of The BioPharm Brief covers the first approved PROTAC therapy for breast cancer, UCB’s planned acquisition of Candid Therapeutics, and new clinical data from Takeda Pharmaceutical Company in primary immunodeficiency.

The opening plenary session at this year’s AAPS National Biotechnology Conference will spotlight AI and NAMs as tools that advance predictive toxicology and human-relevant models to improve drug safety and translational research.

The FDA has approved vepdegestrant, the first PROteolysis TArgeting Chimera protein degrader therapy, for estrogen receptor gene-mutated ER+/HER2- advanced breast cancer, offering a new option for patients with endocrine-resistant disease.

UCB’s planned $2.2 billion acquisition of Candid Therapeutics strengthens its immunology pipeline with bispecific T-cell engagers, led by cizutamig, a BCMA/CD3-targeting antibody in early-stage trials for autoimmune diseases.

According to phase 2/3 trial data, Takeda’s TAK-881 demonstrates reduced infusion volume and shorter administration time while maintaining protective IgG levels in primary immunodeficiency patients.

In today’s podcast, we're seeing microbiome therapies gain FDA Fast Track status, Leo Pharma expand into gene therapy via acquisition, and automation improving AAV manufacturing efficiency.