Jul 19, 2026
Amgen detailed its T-cell engager and precision therapy strategy at Citi's 2026 summit. GT Biopharma, Onco-Innovations, Oncotelic, and Samsung Biologics also advanced AI and organoid platforms in drug development.
Apr 29, 2026
Global biologics market projected to grow to USD 1.28 trillion by 2035; Japan cell and gene therapy market to reach USD 2.15 billion by 2034; Japan biologic drug lifecycle management market to hit USD 9.69 billion by 2033.
Aug 08, 2026
CAR-T therapy reaches 150 patients in Ireland and expands into autoimmune trials for lupus and MS. Kyverna's miv-cel nears FDA approval for stiff person syndrome, and new research links gene variants to CAR-T outcomes.
Jul 13, 2026
Cue Biopharma appointed Dominic Borie as chief medical officer and R&D head as it advances CUE-221 (Phase 2 data expected Q3 2026) and CUE-401 (Phase 1 start Q4 2026). He brings over 20 years of immunology and clinical development experience. The company recently raised $50M to support clinical development.
Jun 05, 2026
Colorado's Prescription Drug Affordability Board imposed a price cap on Enbrel, making it the first U.S. state to cap a specific drug's price. Amgen is suing to block the cap, arguing it interferes with federal patent law protections for innovative drugs. The federal court is considering whether to issue a temporary injunction, with a ruling expected soon.
May 03, 2026
ByteDance is expanding its AI drug-discovery work through Anew Labs and US hiring for its Seed AI team. Anew Labs has presented AI-developed therapies and molecular modeling work at international conferences.
Apr 24, 2026
The iPSC-derived NK cells pipeline includes 12+ active players and 15+ drugs in development. FT522 is in Phase I, while CNTY-101 and NCR300 are among other programs in the clinic.
Apr 22, 2026
Astellas terminated its phase 1 ASP5502 study in Sjögren’s syndrome as Novartis said the FDA granted breakthrough therapy designation to ianalumab. Novartis plans global regulatory submissions from early 2026 after positive phase III data.
Apr 21, 2026
Eli Lilly and Company has agreed to acquire Orna Therapeutics for up to $2.4 billion in cash. The deal includes ORN-252, a clinical-trial-ready CD19-targeting in vivo CAR-T therapy for B cell-driven autoimmune diseases.
Apr 20, 2026
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Apr 20, 2026
Asahi Kasei has started a Phase I clinical trial in Japan for AK1940, a peptide-based investigational compound for autoimmune diseases. The study will assess pharmacokinetics, safety and tolerability in healthy volunteers.
Apr 07, 2026
CRISPR Therapeutics reported a $581.6 million net loss in 2025 with revenue of just $3.5 million, while continuing to advance its gene-editing pipeline including the approved CASGEVY therapy and next-generation CAR T cell programs. The company maintains strategic partnerships and expects current funds to support operations for at least 24 months.
Apr 06, 2026
Blackstone closed its sixth dedicated life sciences fund at a $6.3 billion hard cap, the largest private fund raised for the sector. The vehicle is nearly 40% larger than its 2020 predecessor and targets late-stage drug assets.
Mar 30, 2026
The National Institute of Allergy and Infectious Diseases has been instructed to remove "biodefense" and "pandemic preparedness" language from its website, signaling a major shift away from these research priorities. NIH leadership says the institute will now focus on current infectious diseases and basic immunology rather than predicting future threats. Public health experts warn this could leave the U.S. less prepared for future health emergencies.
Mar 24, 2026
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
Mar 16, 2026
HCW Biologics regained compliance with Nasdaq listing rules and completed a follow-on offering priced at $0.6055 per unit to raise approximately $1.5 million for clinical development of immunotherapies targeting chronic inflammation.
Mar 14, 2026
YolTech Therapeutics received FDA approval for its IND application for YOLT-202, an in vivo gene-editing therapy for Alpha-1 Antitrypsin Deficiency. Interim data from an ongoing trial showed rapid increases in AAT levels to normal range with favorable safety.
Mar 12, 2026
Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.
Mar 09, 2026
Dianthus Therapeutics will host a conference call on March 9, 2026, to discuss interim responder analysis results from Part A of the Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Mar 06, 2026
A Phase 1 trial of azer-cel, a CAR T-cell therapy using donor T-cells to target B-cells, is recruiting patients with progressive multiple sclerosis at eight U.S. sites. Separately, multiple randomized trials are comparing hematopoietic stem cell transplantation against high-efficacy disease-modifying therapies.