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NIH to review paused grant applications — Agreement reopens scientific review
After litigation over diversity‑related directives, the National Institutes of Health agreed to evaluate hundreds of paused grant applications on scientific merit, according to court filings...
U.S. regulatory landscape frays — Chaotic uncertainty and new FDA contracting plan
Life‑sciences firms ended 2025 facing regulatory turbulence as agencies shifted practices and new leadership signaled structural changes. Industry analysts described the year as marked by “chaotic...
Funding pullback: private investment in tools and diagnostics drops 20% in H2 2025
Private financings for life‑science tools and diagnostics firms fell roughly 20% year‑over‑year in the second half of 2025, according to transaction analyses. Total H2 investment dropped to about...
Drug programs cut — Verastem and Genmab end trials amid pivots
Biotechs continued to reshape pipelines as late‑stage and early‑stage programs were terminated or reprioritized. Verastem Oncology halted a Phase 1/2 lung cancer study of its MEK inhibitor Avmapki...
Federal judge halts 340B rebate pilot — court pauses rollout
A federal judge in Maine has blocked the Health Resources and Services Administration’s 340B Rebate Model Pilot Program, pausing an initiative that would have allowed drugmakers to offer rebates...
FDA greenlights Omeros’ narsoplimab: first TA‑TMA treatment
The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) for treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA‑TMA), marking...
Novartis bets big on India: builds largest R&D hub outside Basel
Novartis is expanding drug development operations in India, positioning the country as a major global R&D hub with a workforce exceeding 9,000 employees. Company officials said Indian teams now...
Insilico caps year with Hong Kong IPO — AI drug discovery listed
Insilico Medicine, an AI‑driven drug discovery company, completed a Hong Kong initial public offering, marking a high‑profile exit for an AI-native biotech. The listing capped a multiyear effort...
Biotech’s groove is back — XBI jumps on M&A and lower rates
Biotech equities rallied heading into 2026 as the sector benefited from renewed M&A activity and easing rate expectations, driving a meaningful bounce in the SPDR S&P Biotech ETF (XBI). Industry...
Late‑stage failure sinks brittle‑bone programs — stocks crater
Two Phase III programs of setrusumab failed to meet primary endpoints, prompting Ultragenyx Pharmaceutical and Mereo BioPharma to suspend plans and triggering dramatic market reactions. The...
China accepts Hutchmed NDA — Asia reshapes global biotech playbook
China’s National Medical Products Administration accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), granting priority review based on a single‑arm phase II registration study in intrahepatic...
Obesity deals dominate 2025 — pricing and pill wars heat up
Deal activity in 2025 centered on obesity therapeutics as GLP‑1 receptor agonists and next‑generation candidates drew major investor and corporate interest. Deal flow reflected competition to...
2025 marks breakthrough year for in‑vivo gene therapies — momentum builds
The year saw notable advances in in‑vivo gene therapy delivery and efficacy, with multiple preclinical and early clinical reports resolving longstanding delivery challenges and enabling broader...
ADCs’ breakout 2025 — new architectures broaden promise
Antibody‑drug conjugates (ADCs) experienced a breakout year as innovations in targets, linkers, payloads and conjugation chemistries expanded their therapeutic potential beyond the classic...
FDA clears Yartemlea: first approved therapy for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corporation’s Yartemlea (narsoplimab) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first...
Judge halts 340B rebate pilot: rebate model frozen ahead of Jan. 1
A federal judge in Maine issued a temporary restraining order blocking the Health Resources and Services Administration’s 340B Rebate Model pilot that would have let manufacturers offer rebates...
China approves Innovent’s ipilimumab–neoadjuvant option for MSI‑high colon cancer
China’s National Medical Products Administration granted approval to Innovent Biologics’ Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as a neoadjuvant therapy for stage IIB–III...
China accepts Hutchmed FGFR NDA: priority review for fanregratinib
Hutchmed announced that China’s NMPA accepted the NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy, and granted the submission priority review for intrahepatic cholangiocarcinoma. The...
Sanofi snaps up Dynavax assets — HBV vaccine and shingles candidate join pipeline
Sanofi added hepatitis B vaccine and a shingles clinical candidate to its vaccine portfolio through the acquisition of select Dynavax assets, the companies reported. The deal broadens Sanofi’s...
Insilico caps year with Hong Kong IPO — AI drug developer raises proceeds
Insilico Medicine closed a Hong Kong initial public offering, raising gross proceeds that position the AI‑drug discovery company for expanded platform development and clinical advancement. The...