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May 26, 2026
The FDA granted Breakthrough Device Designation to TOBY Inc.'s urine-based Alzheimer's diagnostic test and Instanosis Inc.'s Xylazine Rapid Test (Urine), accelerating development of both non-invasive diagnostic technologies.
May 16, 2026
CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
May 11, 2026
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
May 04, 2026
The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
May 01, 2026
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
Apr 22, 2026
Peptris has raised INR 70 crore ($7.7 million) in a Series A round to advance programs toward clinical readiness and expand its AI-led drug discovery pipeline over 24 months.
Apr 20, 2026
Oncotelic Therapeutics announced expanded international intellectual property coverage for OT-101 across neurology, oncology and CNS drug-delivery technologies. The company also highlighted biotech valuation trends tied to clinical progress and its 45% stake in GMP Bio.
Apr 16, 2026
Lunai Bioworks said it received U.S. Patent No. 12,369,861 for debiasing data in drug discovery predictions. The patent covers multimodal data standardization and structural bias removal before predictive modeling.
Apr 13, 2026
NVIDIA and Eli Lilly announced a $1 billion AI co-innovation lab as AI drug discovery expands across research, trials and manufacturing. Companies including Recursion and Tempus are using large biological and clinical datasets to speed development and support precision medicine.
Apr 12, 2026
The global API market is projected to grow to USD 198.39 billion by 2030 from USD 144.20 billion in 2025, at a 6.6% CAGR. Oncology, rare disease and diabetes pipelines are key growth drivers.
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 07, 2026
The cell surface markers detection market is projected to grow from $7.01 billion in 2026 to $13.33 billion by 2034, driven by increasing adoption of flow cytometry and applications in immunotherapy research. The market serves pharmaceutical, biotechnology, academic, and clinical research organizations through various workflow stages including sample preparation and cell analysis.
Apr 03, 2026
MacroGenics faces critical 2026 milestones for its ADC pipeline, including Phase 1 data for MGC026 and regulatory resolution for lorigerlimab. The company has financial runway through 2027 and plans IND submission for MGC030 in Q3 2026. Key investor events include ASCO abstract releases and financial results in Q2 2026.
Apr 02, 2026
China's regulatory reforms since 2015 have streamlined clinical trial and drug approval processes, accelerating development of advanced therapies like CAR-T and bispecific antibodies. These changes have boosted investor confidence and created opportunities for global pharmaceutical partnerships with Chinese biotech companies that have innovative pipelines but lack international marketing capabilities.
Apr 03, 2026
The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
Apr 02, 2026
Industry surveys reveal patient access programs are converging on hybrid models but face significant challenges with technology enablement, interoperability gaps, and policy uncertainty. Nearly 60% of programs now use hybrid structures combining internal and external resources, while more than half of organizations report being unprepared for interoperability requirements.
Apr 02, 2026
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
Apr 01, 2026
Market analysis reports project substantial growth through 2033 across sarcopenia treatments, oncology injection drugs, and ASO-based therapies. Major pharmaceutical companies including Pfizer, Merck, Roche, Novartis, and Amgen feature prominently across all three therapeutic areas. The reports cover market segmentation, geographic analysis, and competitive landscapes for each sector.
Mar 31, 2026
The global advanced drug delivery systems market is projected to grow from $255 billion in 2024 to $439.7 billion by 2034 at a 5.6% CAGR. Cardiovascular disease applications dominate with 37.8% market share, while North America leads regionally with 41.3% of the market. Emerging technologies include 3D-printed drug implants, smart hydrogels, and magnetic nanofiber platforms.
Mar 30, 2026
The artificial intelligence in drug discovery market is projected to grow from USD 3.25 billion in 2026 to USD 10.29 billion by 2031, representing a 25.94% CAGR. AI technologies are accelerating drug discovery timelines, reducing costs, and improving success rates through advanced analytics and machine learning. North America leads market adoption while Asia-Pacific emerges as a high-growth region driven by expanding biotechnology sectors.
