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Regulatory approvals and FDA actions
The FDA approved Moderna’s mRNA influenza vaccine for older adults, marking the first licensed flu shot using messenger RNA technology. The decision comes after a high-profile review turnaround in...
Immunology and oncology translational breakthroughs
Memorial Sloan Kettering researchers identified a molecular switch, ZFP36L2, that governs gut-cell survival programs—and colorectal cancer appears to hijack the same mechanism to enable spread....
AI-driven drug discovery and early pipeline nomination
Insilico Medicine nominated ISM9077, an AI-designed inhibitor targeting an undisclosed “Target Y,” as a preclinical candidate spanning dry age-related macular degeneration, uveitis, and dry eye...
Funding and IPO momentum for biotech
Attovia Therapeutics priced an upsized IPO raising $289 million to fund clinical development of its immune disorder pipeline and broaden R&D in 2027. The listing extends a stretch of biotech...
Precision oncology diagnostics and MRD expansion
Natera submitted its Signatera molecular residual disease assay to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is supported by IMvigor011 data in...
Clinical development shifts and trial portfolio management
Sanofi suspended its Phase 2 bronchiectasis study of SAR445399 in non-cystic fibrosis bronchiectasis, citing strategic business reasons. The trial began in April and targeted a reduction in mucus...
HIV prevention performance and market durability debate
Gilead said Yeztugo generated $232 million in Q2 sales, beating Wall Street estimates as its twice-yearly HIV prevention franchise pushed above $1 billion per quarter for the first time. Company...
Genetic diagnostics expansion and revenue growth
BillionToOne plans to launch an expanded Unity Fetal Risk Screen NIPT offering plus a tissue-of-origin add-on for its Northstar Select liquid biopsy assay. The company tied the roadmap to rising...
Clinical trial and IND progress in oncology
Brightpath Biotherapeutics received FDA IND clearance for BP-2202, enabling a first-in-human Phase I trial in patients with relapsed or refractory multiple myeloma. The company said dosing is...
Deal making and business combinations in CNS therapeutics
Supernus and Indivior agreed to an all-stock $1.8 billion merger that will combine their CNS and addiction portfolios. The deal, expected to close in the second half of 2026 subject to approvals,...
Regulatory approvals and labeling decisions
The FDA approved Takeda’s orexin receptor agonist Orzeyful (twice-daily) for narcolepsy type 1, giving clinicians a new mechanism-based option for a disorder tied to orexin neuron deficiency. The...
Precision diagnostics for oncology
Natera submitted its Signatera molecular residual disease (MRD) test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is backed by IMvigor011, a...
CDMO, sequencing operations, and leadership transitions
PacBio’s leadership shifted after CEO Christian Henry resigned and COO Mark Van Oene was appointed to lead the company. Henry, who took the top role in 2020, oversaw PacBio’s acquisition of...
Biotech IPO momentum and public-market fundraising
Attovia Therapeutics priced an upsized IPO to raise $289 million, extending a streak of large biotech offerings and funding expansion of its immunology and inflammation portfolio into 2027. The...
AI-enabled drug discovery moving toward the clinic
A new ASCO-delivered analysis reports that AI-driven drug discovery has moved into measurable interventional human development, counting 117 AI-enabled therapeutic assets across 63 companies...
Clinical-stage trial and drug update in obesity competition
Eli Lilly reported Q2 results that beat expectations, with tirzepatide-related revenue accounting for 64% of total sales and helping lift the company’s full-year outlook. Analysts pointed to...
Cancer biology: targeted drug resistance reversal
Researchers at Baylor College of Medicine reported preclinical evidence that an experimental compound, CS18, can resensitize cancer drug-resistant tumors to existing therapies. The compound...
Oncology M&A: radiopharma consolidation
Curium agreed to buy Lantheus in a deal valued up to $8 billion, pairing Curium’s global radiopharmaceutical manufacturing network and theranostics pipeline with Lantheus’ U.S. radiodiagnostics...
Biotech funding and pipeline: nervous system innovation via AI validation
Recursion and Genentech said they will co-develop a neuroscience small-molecule program after Genentech accepted the first validated target option from an AI-generated map. The milestone includes...
Regulatory and ethics controversy in gene editing transparency
STAT+ reported that a gene-editing trial in China faced renewed scrutiny after disclosure that a child died in a personalized CRISPR program led through a regulatory pathway that allows hospitals...