Medical Device
Tourmaline Bio’s Heart Drug Pacibekitug Shows Promise Against Cardiovascular Inflammation, Targets Competition with Novo, CSL
Tourmaline Bio; heart drug; pacibekitug; cardiovascular inflammation; inflammation markers; Novo Nordisk; CSL; Phase 2 trial; FDA; IL-6
Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost
Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption
Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis
Vyvgart Hytrulo, prefilled syringe, FDA approval, self-administration, generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), DTC campaign, patient empowerment
Teva plots thousands of job cuts as restructuring drive enters ‘acceleration’ phase
Workforce reduction (8%), $700 million cost savings, Strategic overhaul, Generics to biopharmaceuticals pivot, Operational streamlining, R&D investment
FDA lifts clinical hold on Atara’s Epstein-Barr T-cell programme
United States Food and Drug Administration, Study on Hold, Atara, Hoist device, Atara ‘s, EBVALLO
HR25: LifeSignals launches cardiac monitoring patch to compete with iRhythm, Philips
Preventive monitoring, Plaque (lesion), Philips, Heart, iRhythm, LifeSignals, Medical Devices
Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg
United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible
Third Harmonic Bio to Liquidate, Selling Key Urticaria Drug Asset THB335
Third Harmonic Bio liquidation , THB335 drug sale , chronic spontaneous urticaria (CSU) , KIT inhibitor , biopharma exit strategy , clinical-stage biotech , shareholder value maximization
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
Dexcom extends G7 sensor wear time to 15 days with latest FDA nod
United States Food and Drug Administration, sensor (device), Continuous glucose monitoring, MSH5 gene, Accurate (qualifier), Extension, wear time, day