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Axsome priority review: FDA sets April 30 PDUFA for AXS-05
The FDA accepted and granted priority review of Axsome Therapeutics’ supplemental NDA for AXS-05 to treat agitation in Alzheimer's disease, assigning a PDUFA date of April 30. The agency’s...
Corcept CRL — regulator rejects relacorilant, company pivots to ovarian cancer
The FDA issued a complete response letter for Corcept Therapeutics’ relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), asking for additional evidence of efficacy and...
Vanda’s Nereus greenlight: first new motion‑sickness drug in four decades
The FDA approved Vanda Pharmaceuticals’ oral tradipitant (Nereus) for prevention of vomiting induced by motion, marking the first new prescription motion‑sickness drug in more than 40 years....
Omeros greenlight: FDA approves Yartemlea for transplant‑related TA‑TMA
The FDA approved Omeros Corporation’s Yartemlea (narsoplimab), making it the first approved therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The...
NIH reopens stalled grants; judge blocks 340B rebate pilot
The NIH agreed to evaluate hundreds of grant applications that had been paused under new administration directives, committing to scientific‑merit review without applying the challenged...
Biotech’s groove returns: XBI rally and analysts call 2025 an inflection year
The biotech sector closed 2025 with a strong rally in exchange‑traded funds such as XBI, driven by renewed M&A activity, easing rate expectations and improving capital markets access. Industry...
China regulator keeps momentum: Hutchmed NDA accepted, Innovent ipilimumab approved
China’s NMPA accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, granting priority review based on a single‑arm phase II...
ADCs accelerate: field breakout and a $40M SPV to push Oz‑V to registrational trial
After a year of expanded ADC design innovations, the antibody‑drug conjugate (ADC) field is entering a commercialization inflection with new targets, linkers and payloads reported across...
Gene therapy momentum: in vivo gains and SYNGAP1 restoration
Industry reviews label 2025 a breakthrough year for in‑vivo gene therapies, citing multiple preclinical and clinical advances that improved delivery, specificity and efficacy. In that landscape, a...
IPO wave: AI drug discovery and surgical robotics go public in Hong Kong
Two high‑profile listings targeted Hong Kong capital markets as companies pushed to fund R&D and international expansion. Insilico Medicine closed a Hong Kong IPO, delivering proceeds to...
AbbVie signs T-cell engager deal in China — Zelgen's DLL3 program expands
AbbVie struck a licensing and development deal with Zelgen Biopharmaceuticals to advance a clinical-stage DLL3-targeted T‑cell engager in China. The agreement gives AbbVie access to Zelgen’s...
Vanda gets FDA approval for motion‑sickness pill: Nereus cleared
Vanda Pharmaceuticals won FDA approval for Nereus, an oral treatment the company says is the first new medicine for motion sickness in more than four decades. The approval clears the way for a...
FDA rejects Corcept’s cortisol modulator — relacorilant denied for Cushing’s
The FDA issued a rejection for Corcept Therapeutics' selective cortisol modulator relacorilant, denying approval for the treatment of Cushing’s syndrome. Corcept disclosed the decision and will...
FDA approves Omeros’ narsoplimab — first therapy for TA‑TMA cleared
The FDA approved Omeros Corporation’s narsoplimab (Yartemlea) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first approved therapy for this...
China approves Innovent ipilimumab — Hutchmed’s FGFR NDA accepted for priority review
China’s NMPA approved Innovent Biologics’ Tabosun (ipilimumab IBI‑310) in combination with sintilimab as a neoadjuvant treatment for resectable MSI‑high or mismatch repair‑deficient colon cancer....
BioAtla, GATC form $40M SPV to advance ozuriftamab — Phase 3 planned in OPSCC
BioAtla and GATC Health announced a $40 million special purpose vehicle (SPV) transaction to fund a Phase 3 registrational trial of ozuriftamab vedotin (Oz‑V; CAB‑ROR2‑ADC) in second‑line and...
Insilico caps year with Hong Kong IPO — AI drug discovery firm raises fresh capital
Insilico Medicine completed a Hong Kong initial public offering, raising gross proceeds that mark the company’s successful public market debut after multiple attempts. The offering underscores...
Startups stumble — Nido winds down; setrusumab Phase III failures rattle Mereo, Ultragenyx
Boston‑area startup Nido Biosciences said it will wind down operations in early 2026 after Phase 2 data missed expectations, terminating its development plans. Separately, two Phase III trials of...
NIH to re‑review stalled grant applications — court settlement reopens scientific review
The U.S. National Institutes of Health agreed to evaluate hundreds of grant applications that were paused under new administration directives restricting diversity‑related research priorities. The...
Judge halts 340B rebate pilot — implementation blocked ahead of Jan. 1 rollout
A federal judge in Maine issued a temporary restraining order blocking the Health Resources and Services Administration’s 340B Rebate Model Pilot Program, which would have allowed biopharma...