Regulatory & Policy
Taveos' unraveling accelerates as UK joins global regulatory retreat
A rare autoimmune vasculitis treatment has lost its UK authorization after regulators concluded that data underpinning its approval can no longer be...
uniQure files AMT-130 BLA after stop-start FDA path
uniQure N.V. (Nasdaq: QURE) has submitted a Biologics License Application (BLA) to the US FDA seeking accelerated approval of ifezuntirgene inilparvovec...
FDA grants breakthrough status to Juniper hypoxia tracer for radiation de-escalation in HPV-positive OPC
Bedminster, New Jersey-based Juniper Biosciences announced receipt of US FDA Breakthrough Therapy Designation (BTD) for JBS-003 (18F-fluoromisonidazole, or...
10x wins USD 4.8m willful-infringement verdict against Qiagen-owned Parse
A federal jury in the US District Court for the District of Delaware has found that Parse Biosciences — now a subsidiary of Netherlands-based Qiagen (NYSE:...
FDA expands Stelara into pediatric ulcerative colitis with non-TNF mechanism
Stelara (ustekinumab), the anti-IL-12/23 monoclonal antibody marketed by Janssen Biotech, has received US FDA approval for moderately to severely active...
FDA approves Besremi for essential thrombocythemia, first new ET drug in nearly 30 years
The US FDA has approved Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), marking the first new...
Enhertu plus pertuzumab breaks decade-long first-line HER2-positive breast cancer status quo
The European Commission has approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adults with...
FDA approves Takeda's Mimrylo as first hepcidin mimetic for polycythemia vera
The US FDA has approved Mimrylo (rusfertide), the first hepcidin mimetic peptide cleared for polycythemia vera (PV), giving Takeda (NYSE: TAK) a...
BioMarin lands 20% Yuviwel royalty in Ascendis patent settlement
A patent dispute that spanned multiple continents and two of the most closely watched rare disease drugs has ended with BioMarin Pharmaceutical Inc....
FDA approves Lisraya as first targeted therapy for dermatomyositis
The US FDA has approved Lisraya (brepocitinib) 30 mg for the treatment of adults with dermatomyositis, making it the first targeted therapy approved for the...
HutchMed’s Atled wins China approval for FGFR2-driven bile duct cancer
China's NMPA has conditionally approved Atled (fanregratinib), an oral selective fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor developed by...
Pfizer and BioNTech's XFG-adapted Comirnaty given FDA clearance for fall 2026 rollout
The US FDA has approved a supplemental Biologics License Application (sBLA) for Comirnaty XFG (COVID-19 vaccine, mRNA), the 2026–2027 XFG-adapted...
FDA approves Gilead's Bixlenvo to simplify complex HIV regimens
The US FDA has approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen (STR) for HIV-1 treatment in virologically...
FDA approves Moderna's updated 2026-2027 COVID-19 vaccines for high-risk and older adults
The US FDA has approved updated 2026-2027 formulations of both Spikevax and mNexspike (COVID-19 Vaccine, mRNA) from Cambridge, Massachusetts-based Moderna...
AbbVie seeks EMA approval for Skyrizi subcutaneous induction in Crohn's disease
AbbVie (NYSE: ABBV) has submitted an application to the European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab) subcutaneous (SC)...
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