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Latest Biotech News

Regulatory compliance action on GLP-1 API import safeguards

May 22, 2026

FDA issued a warning letter to Harbin Jixianglong Biotech after inspectors alleged the company attempted to circumvent recently introduced GLP-1 receptor agonist import restrictions. The regulator...

Parkinson’s targeted LRRK2 therapy fails to hit primary objective

May 22, 2026

Biogen and Denali Therapeutics disclosed that their experimental Parkinson’s therapy targeting LRRK2 failed to slow the degenerative disease in a randomized trial. The study enrolled 648 adults...

Obesity triple-agonist retatrutide posts new Phase 3 weight-loss results

May 22, 2026

Eli Lilly reported new Phase 3 top-line results for retatrutide in obesity, with all tested doses meeting primary and key secondary endpoints and driving average weight loss in the range of 19% to...

FDA approves expanded ctDNA liquid genomic profiling for multiple cancer CDx uses

May 22, 2026

Guardant Health received FDA approval for its upgraded Guardant360 Liquid CDx test, providing broader genomic and epigenomic profiling from a single blood draw. The company said the test covers a...

Biotech corporate: Seer board rejects renewed takeover offer

May 22, 2026

Seer said its board unanimously rejected a renewed takeover bid from investor group led by Bradley Radoff and Michael Torok, despite the offer structure increasing contingent value terms. The...

FDA clearance for allogeneic CAR-T trial in autoimmune disease

May 22, 2026

Hangzhou Qihan Biotech obtained FDA IND clearance for QT-019C, a universal allogeneic CAR T-cell therapy engineered to target both CD19 and BCMA for autoimmune diseases. The company said the...

Lilly continues genetic-medicine M&A with Engage Bio acquisition

May 22, 2026

Eli Lilly agreed to acquire Engage Biologics in a deal worth up to $202 million, adding preclinical non-viral DNA delivery capabilities to its genetic medicines pipeline. Engage’s platform, called...

Biotech venture: RA Capital-backed SPAC raises $75M for a biotech merger

May 22, 2026

RA Capital Management’s blank-check entity Research Alliance III raised $75 million in its IPO to merge into an existing biotechnology company. The SPAC sold 7.5 million shares at $10 each and...

Oncology trial readouts at ASCO26

May 21, 2026

Multiple oncology readouts tied to ASCO26 are pointing to expanding options across lung and head-and-neck cancer, with companies using combination strategies aimed at both efficacy and...

Next-gen obesity pipeline moves toward regulatory milestones

May 21, 2026

Eli Lilly’s next-generation obesity franchise advanced further with new Phase 3 topline data for retatrutide, reinforcing the company’s competitive positioning versus both GLP-1 and dual-agonist...

FDA expands companion diagnostics for targeted lung therapy

May 21, 2026

The FDA approved an expanded companion diagnostic label for Foundation Medicine’s FoundationOne CDx to support EMD Serono’s Tepmetko (tepotinib) in metastatic NSCLC with MET exon 14 skipping...

Cancer diagnostics scale up with Guardant360 Liquid CDx approval

May 21, 2026

The FDA approved Guardant Health’s upgraded Guardant360 Liquid CDx, expanding blood-based tumor profiling to a much larger genomic footprint for cancer treatment decision-making. Guardant said...

Regulatory and policy implications for laboratory-developed testing (LDTs)

May 21, 2026

US lawmakers introduced a bill to update CLIA oversight for laboratory-developed tests, aiming to restore more structured governance following a 2025 court decision that positioned LDTs as...

AI integration and enterprise drug discovery acceleration

May 21, 2026

Bristol Myers Squibb expanded its enterprise AI strategy by partnering with Anthropic to deploy Claude across global operations, aiming to move beyond chat-only use cases. The collaboration will...

CAR T innovation and early-stage pipeline movement

May 21, 2026

CAR T manufacturing and development continued to progress through early regulatory and deal announcements spanning autoimmune targeting and next-generation bivalent antigen designs. Hangzhou...

Obesity and cardiometabolic drug strategy beyond weight loss

May 21, 2026

Beyond primary weight-loss efficacy, companies are increasingly using cardiometabolic risk-factor readouts and broader endpoint coverage to support obesity drug value propositions. Coverage of...

Dealmaking and pipeline funding in biotech

May 21, 2026

Biotech financing and M&A activity continued to accelerate through high-value deals and public-market bids aimed at extending clinical programs. Parabilis Medicines filed for an IPO while...

Biotech R&D platform scaling: diagnostics, data, and manufacturing capabilities

May 21, 2026

Across development platforms and enabling technologies, new investments and product roadmaps are focusing on scaling data capture, manufacturing flexibility, and agentic support for drug...

Obesity drug efficacy milestone for retatrutide

May 21, 2026

Eli Lilly’s next-generation triple-acting obesity drug retatrutide cleared another major milestone in Phase 3, with “TRIUMPH-1” data showing sustained weight loss over 80 weeks. At the highest 12...

Obesity pipeline competitiveness—new retatrutide readout context

May 21, 2026

A second report on retatrutide reframed the Phase 3 “TRIUMPH-1” dataset as a competitiveness test against both Lilly’s existing GLP-1/GIP product Zepbound and the broader market leaders. The new...