Ipsen moves closer to EU approval for Ojemda in BRAF-driven childhood brain tumors
Ipsen nears EU approval for Ojemda in BRAF-driven pediatric glioma. Explore regulatory impact, clinical implications, and long-term risks.
Pharma & Biotech
Pharma & Biotech
Can X4 Pharmaceuticals and Norgine unlock EU access to the first targeted WHIM therapy?
EMA backs mavorixafor for WHIM syndrome. Explore what EU approval could mean for access, evidence standards, and rare immunology treatment.
Pharma & Biotech
Avacta (AIM: AVCT) FAP-Exd data challenges Enhertu on tumor selectivity ahead of Phase 1 start
Avacta Therapeutics (AIM: AVCT) has published preclinical data showing that its FAP-targeted payload delivery platform, FAP-Exd (AVA6103), outperforms the marketed antibody drug conjugate trastuzumab deruxtecan across three pharmacokinetic measures, with a Phase 1 clinical trial expected to begin in the first quarter of 2026. What the AI-generated comparator actually enables The methodological choice here deserves
Pharma & Biotech
Scynexis expands SCY-247 program with IV SAD and MAD trial launch
SCYNEXIS advances IV SCY-247 into Phase 1 for invasive candidiasis. Explore what this means for resistance and regulation.
Medical Devices & Diagnostics
Biomerica’s responder data raises new questions about diet-driven IBS management
Biomerica reports real-world IBS responder data and Medicare coverage. Explore what this means for adoption, reimbursement, and competition.
Pharma & Biotech
Gossamer Bio Phase 3 PROSERA results: what seralutinib’s near miss means for pulmonary arterial hypertension
Gossamer Bio’s Phase 3 PROSERA data for seralutinib in PAH missed its primary endpoint. Read what this means for regulators and clinicians.
Medical Devices & Diagnostics
Can ClearNote Health’s Avantect test finally close the early detection gap in pancreatic cancer
ClearNote Health’s updated Avantect test improves pancreatic cancer detection in high-risk patients. Find out what this changes for early screening strategies.
Pharma & Biotech
Quiver Bioscience deal shows how Angelini Pharma is rethinking genetic epilepsy innovation
Angelini Pharma partners with Quiver Bioscience to discover new genetic epilepsy targets. Find out what this changes for drug discovery and patients.
Pharma & Biotech
Why Beren Therapeutics’ adrabetadex NDA could redefine approval standards in ultra-rare pediatric disease
FDA acceptance of adrabetadex puts disease modification for infantile-onset NPC under review. See what this decision could change for rare disease approvals.
Medical Devices & Diagnostics
What Bristol Myers Squibb’s luspatercept results reveal about the future of alpha thalassemia care
Bristol Myers Squibb reports positive luspatercept data in alpha thalassemia. Find out what this could change for treatment and regulation.