ORG – Page 11 – Talk Bio

Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

2 weeks ago talkbio0Tagged AChR-Ab, Adaptation, Argenx, expansion, Labels (device), LRP4 gene, Musk, Myasthenia Gravis, Phase 3, SERON, Seronegative, triple seronegative, United States Food and Drug Administration, Vyvgart

Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion

MannKind to Acquire scPharmaceuticals in Up to $360M Deal

2 weeks ago talkbio0Tagged Acquisition, cardiometabolic diseases, cardiorenal medicine, FDA-approved, FUROSCIX, MannKind, merger agreement, ReadyFlow Autoinjector, scPharmaceuticals, Tender

MannKind; scPharmaceuticals; acquisition; Furoscix; cardiorenal medicine; cardiometabolic diseases; FDA-approved infuser; ReadyFlow autoinjector; merger agreement; tender offer

CNS Pharmaceuticals Pursues Public Offering to Fund Phase 2 GBM Trial After Cost Cuts

3 weeks ago talkbio0Tagged cash position, Clinical Nurse Specialists, Funding, Glioblastoma, IPO, layoffs, multiforme, public entity

CNS Pharmaceuticals; biotech; layoffs; IPO; public offering; phase 2 trial; glioblastoma multiforme; funding; cash position

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

3 weeks ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

FDA Begins Daily Publication of Drug Adverse Event Data

3 weeks ago talkbio0Tagged Adverse event, Daily, data modernization, drug safety, FAERS, public health medicine (field), real-time monitoring, United States Food and Drug Administration

FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

3 weeks ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

Data Lakes & FAIR Principles: Making Scientific Data Accessible and Actionable

3 weeks ago talkbio0Tagged accessible, Data Lakes, Data Management, Fair Language Proficiency, Findable, Interoperable, Principles, research, Scientific Data

Data Lakes; FAIR Principles; Scientific Data; Findable; Accessible; Interoperable; Reusable; Research Data Management

Trump Locks in 15% Pharmaceutical Tariff Rate for EU, Generic Drugs Exempted

3 weeks ago talkbio0Tagged 15%, brand-name drugs, EU, Evaluation, Generic Drugs, Sectioning technique, tariff, tariff exemption, TNFRSF19 gene, transatlantic trade, Trump administration

15% tariff; pharmaceuticals; EU; Trump administration; generic drugs; trade deal; tariff exemption; brand-name drugs; transatlantic trade; Section 232 investigation