Latest Biotech News

Takeda’s zasocitinib scored statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a top-line Phase 3 readout for moderate-to-severe plaque psoriasis, reported from the...

Parabilis completed a $770.5 million IPO after underwriters exercised their full overallotment option, according to the company’s public-equity reporting. The conformationally stabilized peptide...

Oricell advanced its GPC3-directed strategy in liver cancer, moving its autologous CAR T therapy Ori-C101 into a confirmatory registration Phase 2 trial in patients with GPC3-positive advanced...

SonoThera raised an oversubscribed $125 million in Series B financing, using the capital to advance ultrasound-mediated delivery genetic medicines into clinical development. The round was led by...

Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The...

Amgen escalated its dispute with the FDA over Tavneos (avacopan), seeking an independent review to keep the rare vasculitis drug on the market. The FDA’s action is tied to concerns triggered by...

Industry groups pushed for stronger competitiveness incentives under the EU Biotech Act framework, arguing current provisions are insufficient to restore Europe’s position in biopharma. The call...

Leica Biosystems expanded its strategic collaboration with AstraZeneca and Daiichi Sankyo to scale a TROP2 biomarker assay and computational image analysis workflow for non-small cell lung cancer....

Eli Lilly-backed Abridge expanded its position in clinical trial recruitment and broadened its use cases in life-sciences workflows, backed by an investment through Lilly’s venture arm. The...

Amsterdam UMC has reported the successful conclusion of what it describes as the world’s first Phase 3 trial of an in vivo CRISPR-based therapy, bringing CRISPR gene editing closer to broader...

The FDA has approved an adjuvant combination of pembrolizumab and belzutifan for high-risk clear cell renal cell carcinoma after surgery, positioning the regimen as a new postoperative option for...

Oricell Therapeutics has advanced its GPC3-targeted autologous CAR T therapy, Ori-C101, into a confirmatory registration-directed Phase 2 trial for patients with GPC3-positive advanced...

Amgen is contesting FDA concerns over Tavneos (avacopan), arguing for an independent review as the agency faces pressure to revisit whether the rare vasculitis drug should remain on the market....

SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated genetic medicines into clinical development, with the company targeting Duchenne muscular dystrophy and...

ASO-focused biotech SynaptixBio is pushing the UK’s MHRA to strengthen incentives inside its draft rare disease therapy framework. Dan Williams, the company’s CEO, argues that the current...

Industry groups are calling for stronger competitiveness incentives as the EU prepares for implementation of the EU Biotech Act. Companies and stakeholders say support needs to go beyond...

Baxdrostat (Baxfendy), a selective oral aldosterone synthase inhibitor, has received FDA approval in May 2026 for hypertension, according to the drug’s Phase 3 profile in the BaxHTN program. The...

Takeda’s oral TYK2 inhibitor zasocitinib (TAK-279) showed statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a top-line Phase 3 Latitude Atlas readout for...

Guardant Health said the FDA approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in adults with HER2-mutant advanced non-small cell lung cancer....

The FDA has approved an adjuvant combination of pembrolizumab and belzutifan for high-risk clear cell kidney cancer after surgery, adding a hypoxia-axis HIF-2α inhibitor to standard immune...