In the latest update of our FDA Decision Tracker, we cover the regulator's approval of SUN PHARMA's severe alopecia areata treatment. https://hubs.li/Q02J4f-40 #pharma #regulatory #biospace
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Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis: Subcutaneous ocrelizumab can be delivered in approximately 10 minutes and deliver comparable clinical benefit and safety to the IV formulation. #finance #pharmacy #lifesciences
Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis
pharmacytimes.com
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Plexiform Neurofibromas Targeted by Mirdametinib as FDA Grants Priority Review SpringWorks Therapeutics has received FDA Priority Review for mirdametinib, an investigational MEK inhibitor for treating plexiform neurofibromas in adults and children, with a PDUFA action date set for February 28, 2025. If approved, it could be the first treatment for adults with NF1-PN and a leading therapy for pediatric patients. The New Drug Application and the European Medicines Agency submissions are based on positive Phase 2b ReNeu trial data, showing strong response rates, pain reduction, and improved quality of life. This marks a key milestone for SpringWorks Therapeutics in addressing a significant unmet medical need. For more details please click the link! https://lnkd.in/dkJa2QhA #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
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Subcutaneous Blinatumomab Demonstrates Safety, High Efficacy in Patients With Pretreated R/R B-ALL: The results indicate promising rates of complete response, manageable adverse events, and dose-dependent exposure in both dose groups. #finance #pharmacy #lifesciences
Subcutaneous Blinatumomab Demonstrates Safety, High Efficacy in Patients With Pretreated R/R B-ALL
pharmacytimes.com
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https://lnkd.in/gbD848Kh Key Insights: • 4D-710 exhibits promising and consistent CFTR expression, surpassing normal levels, with seven patients showing significant improvement in Cohorts 1 & 2 (1E15-2E15 vg) Visit MedicoInsights to explore key insights #HealthcareNews #drugs #StayInformed #MedicalNews #drugapproval #HealthTrends #Insights #HealthIndustry #HealthInnovation #4DMT #lungdisease #cysticfibrosis #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights
4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease
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Little is known about switching biologics for #atopicdermatitis in the real world. Mona Shahriari, MD, FAAD and colleagues have shared their experience to better inform clinicians who may be faced with a patient with suboptimal control, tolerability issues, or adverse events. Check out the link below to update your knowledge on this important topic! Link: https://lnkd.in/g9T8GckC
A retrospective multicenter case series of real-world tralokinumab use in dupilumab-experienced patients
jaadcasereports.org
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NICE Approves Etrasimod for Ulcerative Colitis: A New Hope for Patients Aged 16 and Over The National Institute for Health and Care Excellence has endorsed the use of Etrasimod for ulcerative colitis patients who have not responded well to conventional treatments. Etrasimod, sold under the name Velsipity by Pfizer, has shown promising results in clinical trials and is a cost-effective option. The guidance includes a commercial arrangement with the NHS to offer discounts on the drug. NHS England and integrated care boards are required to ensure availability of Etrasimod within a specified timeframe. For more details please click the link! https://lnkd.in/d85SBxXY #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
NICE Approves Etrasimod for Ulcerative Colitis: A New Hope for Patients Aged 16 and Over
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Ciltacabtagene Autoleucel Demonstrates Promising Efficacy, Safety in Real-World Study: The real-world study results of ciltacabtagene autoleucel are comparable to data from the CARTITUDE-1 trial, emphasizing its efficacy and safety. #finance #pharmacy #lifesciences
Ciltacabtagene Autoleucel Demonstrates Promising Efficacy, Safety in Real-World Study
pharmacytimes.com
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#IowaBioMemberNews 🧬 IowaBio member company Novartis recently received FDA approval for its oral monotherapy, Fabhalta! The drug will assist people in managing a rare and serious blood disorder called paroxysmal nocturnal hemoglobinuria (PNH) "Fabhalta is a “new, effective oral medicine” that could allow PNH patients to “reset their expectations of living with PNH,” Bultó said, adding that Novartis will continue to assess Fabhalta in other complement-mediated diseases." Read more: https://ow.ly/CPmq50QgQPp #IowaBio #Biotech #IowaBiotech #Innovation #BioIndustryNews
Novartis Wins FDA Approval for Oral Monotherapy for Rare Blood Disorder | BioSpace
biospace.com
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The development of therapeutics for the treatment of rare diseases can present several challenges to drug developers. Nazim Kanji and Huw Jones explore how #CRO & #CDMO partners can lend a consultative approach to help their clients across all areas of drug development in this article with Pharmafile: https://bit.ly/3wHjSBC
Rare Diseases: Collaboration in Orphan, Rare and Pediatric Drug Development by Nazim Kanji and Huw Jones
quotientsciences.com
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Thoughts on this? >> After pair of failures, PTC finds a path through FDA jungle for Friedreich ataxia med >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #competitivemarketing #pharma #biotech #healthcare
After pair of failures, PTC finds a path through FDA jungle for Friedreich ataxia med
fiercebiotech.com
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