Latest Biotech News

Updated phase 3 RUBY trial findings strengthened the case for dostarlimab plus carboplatin and paclitaxel in dMMR/MSI-H primary advanced or recurrent endometrial cancer. At a median follow-up of...

Researchers at UCLA Health reported preclinical data suggesting a new “cytokine-armored” CAR T design could better handle antigen heterogeneity and immunosuppression in glioma models. The approach...

University of Pennsylvania investigators and Children’s Hospital of Philadelphia clinicians reported meaningful clinical benefits after an mRNA-based CRISPR base-editing treatment for an infant...

The FDA cleared Gilead’s hepatitis D treatment Hepcludex (bulevirtide) nearly four years after an earlier rejection. The first decision in this approval cycle reportedly hinged on manufacturing...

Parabilis filed for an IPO a day after signing an up-to-$2.3 billion strategic research collaboration with Regeneron. The company’s IPO filing (Form S-1) followed a concurrent private placement in...

The FDA issued a warning letter to a Chinese supplier, Harbin Jixianglong Biotech, after inspectors alleged the company used labeling practices that may have circumvented the agency’s GLP-1 import...

Takeda said it plans to appeal an $885 million jury verdict in a pay-for-delay antitrust case. The lawsuit was brought by pharmacies and wholesalers that alleged Takeda delayed generic competition...

New Chinese investigator-initiated trial (IIT) rules are expected to reduce so-called “gray market” activity by tightening oversight while legitimizing pathways for modalities beyond cell and gene...

The FDA has approved datopotamab deruxtecan (Datroway; Dato-DXd) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for...

Phase 3 data slated for ASCO have reinforced the growing competitive push to upgrade frontline treatment for PD-L1–positive NSCLC beyond Keytruda alone. In China’s OptiTROP-Lung05, Merck and...

A prospective randomized placebo-controlled trial presented evidence supporting antenatal N-acetylcysteine (NAC) supplementation to prevent imminent preterm birth in at-risk pregnancies. Conducted...

The EMA’s Committee for Medicinal Products for Human Use moved forward with potential replacement therapy for patients as generic versions of Boehringer Ingelheim’s Ofev (nintedanib) begin to hit...

Gilead secured long-awaited US approval for its hepatitis D treatment Hepcludex (bulevirtide), roughly four years after the FDA previously rejected the drug over manufacturing and distribution...

Parabilis filed for an IPO shortly after signing a collaboration with Regeneron worth up to $2.3B-plus and covering an initial set of five antibody-Helicon conjugate candidates. In a concurrent...

Skape Bio and UW Medicine researchers reported AI-designed miniproteins that can selectively activate or block multiple GPCR targets—addressing a core drug-discovery bottleneck for receptors whose...

FDA issued a warning letter to a Chinese supplier after inspectors found alleged attempts to circumvent recently introduced GLP-1 active pharmaceutical ingredient (API) import restrictions. FDA...

Sino Biological launched XPressMAX™—a cell-free protein synthesis kit designed to accelerate AI-driven high-throughput antibody discovery workflows. The kit enables researchers to synthesize...

Oorja Bio secured a $30M Series A financing led by founding investor Westlake Biopartners to advance its idiopathic pulmonary fibrosis (IPF) and other fibrotic and cardiopulmonary drug pipeline...

The FDA has approved datopotamab deruxtecan-dlnk (Datroway; Dato-DXd) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates...

Gilead won U.S. approval for its hepatitis D drug Hepcludex (bulevirtide), four years after an FDA rejection tied to manufacturing and distribution concerns. The clearance follows the company’s...