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FDA greenlights narsoplimab: first approved therapy for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corp.'s narsoplimab (Yartemlea) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), making it the first...
Phase III failures wipe out value: brittle‑bone program collapses
Two late‑stage trials of setrusumab failed primary endpoints, sending shares of developers Mereo BioPharma and Ultragenyx tumbling and prompting strategic reassessments. The partners reported that...
China approves Innovent’s ipilimumab: neoadjuvant label for colon cancer
China’s National Medical Products Administration granted approval to Innovent Biologics for Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as a neoadjuvant treatment for stage...
Hutchmed’s FGFR drug lands priority review: NMPA accepts fanregratinib NDA
Hutchmed (China) Ltd. secured National Medical Products Administration acceptance and priority review for an NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic...
Insilico goes public in Hong Kong — AI drug discovery rides an IPO wave
Insilico Medicine completed a Hong Kong initial public offering after multiple attempts, raising gross proceeds that signal investor appetite for AI‑driven drug discovery companies. The company is...
Funding cools for tools and diagnostics: private investment slips in H2 2025
Private financings for life‑science tools and diagnostics fell 20% year‑over‑year in H2 2025, according to GenomeWeb/360Dx data, with total investment of $1.21 billion across 38 transactions. The...
ASK Pharm expands China rights: Adlai Nortye licenses pan‑RAS AN‑9025
Adlai Nortye licensed its pan‑RAS(ON) inhibitor AN‑9025 to Jiangsu Aosaikang Pharmaceutical (Ask Pharm) in an exclusive deal that gives Ask Pharm China commercialization rights. The oral small...
Judge blocks 340B rebate pilot: implementation paused ahead of Jan. 1
A federal judge in Maine issued a temporary restraining order halting the Health Resources and Services Administration’s 340B Rebate Model pilot that sought to de‑duplicate discounts for drugs...
Harbour Biomed, Lannacheng tie up on radionuclide‑drug conjugates
Harbour Biomed and Yantai Lannacheng Biotechnology announced a long‑term strategic collaboration to develop next‑generation radionuclide‑drug conjugates for oncology. The partnership combines...
Pipeline attrition and program cuts: Nido wind‑down, Genmab ends bispecific program
Boston‑area startup Nido Biosciences announced it will wind down after Phase II data fell below expectations, while Genmab terminated development of acasunlimab, a bispecific antibody that...
Biotech’s comeback: XBI rallies on M&A, rate relief
Biotech stocks rallied into 2026 as investors priced in renewed M&A activity and a friendlier interest-rate outlook. Exchange-traded fund XBI posted a sharp gain ahead of the JP Morgan Healthcare...
Insilico lands Hong Kong IPO — pivots from AI discovery to SIK inhibitors
Insilico Medicine completed a long-anticipated Hong Kong listing and simultaneously disclosed new internal small-molecule programs. The company raised proceeds after multiple attempts to go...
Obesity deals dominate 2025 — GLP‑1 frenzy reshapes M&A
Deal activity in 2025 centered on obesity therapeutics as GLP‑1 receptor agonists reshaped commercial priorities across biopharma. Companies pursuing complementary mechanisms or delivery formats...
Diagnostics slump: private investment slides while POC wins clearance
Private financing into life‑science tools and diagnostics firms declined materially in H2 2025, with total investment down about 20% year over year, reflecting macro uncertainty and tighter...
FDA greenlights Yartemlea — first approved treatment for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corp.’s narsoplimab (Yartemlea) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first...
China acts fast on oncology: domestic CTLA‑4 cleared, FGFR NDA accepted
China’s National Medical Products Administration granted approval to Innovent Biologics’ ipilimumab (Tabosun) in combination with sintilimab for neoadjuvant treatment of resectable...
Clinical blowup: setrusumab Phase III failures wipe out value for Ultragenyx, Mereo
Two late‑stage Phase III trials of setrusumab failed to meet primary endpoints, forcing Ultragenyx and Mereo into a reassessment of their brittle bone disease programs. The readouts triggered...
2025 an inflection for in vivo gene therapies — delivery advances surface
Multiple groups reported progress in in vivo gene‑editing and delivery in 2025, pushing the modality toward broader clinical translation. New strategies addressed tissue targeting, payload...
Cancer pipeline reshuffle: Verastem pivots, Genmab halts bispecific asset
Verastem Oncology terminated an early‑stage trial of its MEK inhibitor Avmapki in lung cancer and said it will refocus resources on a KRAS‑targeting program. Separately, Genmab ended development...
ADCs break out in 2025 — novel platforms and TRBV12 targets emerge
Antibody‑drug conjugates diversified in 2025 as developers introduced new linkers, payloads and conjugation chemistries to expand target space and therapeutic windows. Industry reports catalog an...