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Zacks News
FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
by Zacks Equity Research
REGN scores FDA approval for Lynozyfic in tough-to-treat multiple myeloma, bolstering its oncology pipeline amid Eylea headwinds.
Is DexCom (DXCM) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Here is how DexCom (DXCM) and Bayer Aktiengesellschaft (BAYRY) have performed compared to their sector so far this year.
RARE's GTX-102 Gets FDA's Breakthrough Status for Angelman Syndrome
by Zacks Equity Research
Ultragenyx Pharmaceuticals' GTX-102 earns FDA Breakthrough status after early data shows sustained progress in Angelman syndrome patients.
KRYS Up 4% on Initiating Dosing in Rare Eye Disease Phase III Study
by Zacks Equity Research
Krystal Biotech rises 4% after dosing begins in a phase III study of KB803 eye drops to treat rare DEB-related corneal damage.
Amarin Soars 27% on Vazkepa Licensing Deal With Recordati in the EU
by Zacks Equity Research
AMRN jumps 27% after inking an exclusive EU licensing deal with Recordati to expand Vazkepa's reach and cut costs.
CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication
by Zacks Equity Research
CHMP recommends a label update for Novo Nordisk's Ozempic after the STRIDE study shows walking improvements in T2D patients with PAD.
NVO Reports New Positive Phase III Data on Mim8 in Hemophilia A
by Zacks Equity Research
Novo Nordisk's Mim8 shows strong safety and patient preference in the phase IIIb hemophilia A study switching from Hemlibra to Mim8.
FDA Extends INCY's Application for Opzelura Label Expansion
by Zacks Equity Research
FDA extends review of Incyte's ruxolitinib cream for children with atopic dermatitis, delaying decision to September 2025.
FDA Approves Gilead's Twice-Yearly Shot for HIV Prevention
by Zacks Equity Research
GILD wins FDA approval for Yeztugo, the first and only twice-yearly injectable PrEP for HIV prevention in the United States.
Bayer Seeks FDA Approval for MRI Contrast Agent Gadoquatrane
by Zacks Equity Research
BAYRY files for FDA nod to gadoquatrane, a low-dose MRI contrast agent backed by strong QUANTI study results.