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FDA Pushes Back Decision Date on Argenx BLA to June
FDA Pushes Back Decision Date on Argenx BLA to June
The FDA has extended its decision date on argenx’s biologics license application (BLA) for subcutaneous efgartigimod for the treatment of adults with generalized myasthenia gravis to June 20. ...
API Distributor LGM Pharma Enters Consent Decree
API Distributor LGM Pharma Enters Consent Decree
A federal court in Florida has issued a consent decree against LGM Pharma, a Boca Raton-based active pharmaceutical ingredient (API) importer and distributor, prohibiting the company from distribut...
NICE Recommends Epidyolex for Tuberous Sclerosis Complex Seizures
NICE Recommends Epidyolex for Tuberous Sclerosis Complex Seizures
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Epidyolex (cannabidiol,100 mg/ml oral solution) for National Health Service (NHS) use as ...
FDA Approves Sutimlimab-jome with Long-Term Safety, Efficacy Data for Cold Agglutinin Disease
FDA Approves Sutimlimab-jome with Long-Term Safety, Efficacy Data for Cold Agglutinin Disease
The FDA has approved an expanded label for sutimlimab-jome (Enjaymo, Sanofi) with new long-term safety and efficacy data for individuals with cold agglutinin disease (CAD), to now include patients...
EU Expands Dupixent’s Authorization for Eosinophilic Esophagitis
EU Expands Dupixent’s Authorization for Eosinophilic Esophagitis
The European Commission (EC) has expanded its marketing authorization for Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) to treat adults and adolescents 12 years and older with eos...
Roche, Boehringer tap biosensor firms for patient studies
Roche, Boehringer tap biosensor firms for patient studies
Roche and Boehringer Ingelheim have both formed partnerships with tech companies this week to develop and deploy wearable biosensor technology for use in clinical trials and patient monitoring. ...
FDA Grants Accelerated Approval to Eli Lilly’s Jaypirca in Mantle Cell Lymphoma
FDA Grants Accelerated Approval to Eli Lilly’s Jaypirca in Mantle Cell Lymphoma
Eli Lilly’s Jaypirca (pirtobrutinib) has gained FDA accelerated approval for treatment of adult patients with relapsed or resistant mantle cell lymphoma after at least two lines of systemic thera...
FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer
FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer
The FDA has approved Stemline Therapeutics’ Orserdu (elacestrant) as the first treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastati...
Cassava Claims Phase 2 Win for Its Alzheimer’s Candidate
Cassava Claims Phase 2 Win for Its Alzheimer’s Candidate
Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator,...
FDA Lifts Clinical Hold on Inhibikase Candidate for Parkinson’s Disease
FDA Lifts Clinical Hold on Inhibikase Candidate for Parkinson’s Disease
The FDA has lifted a clinical hold on Inhibikase Therapeutics’ clinical trial evaluating IkT-148009, its drug candidate for treatment of Parkinson’s disease. ...
FDA Expands Approval for Merck’s Keytruda in NSCLC
FDA Expands Approval for Merck’s Keytruda in NSCLC
The FDA has approved Merck’s blockbuster drug Keytruda (pembrolizumab) as a single agent for adjuvant treatment in adult patients with stage IB, II or IIIA nonsmall-cell lung cancer (NSCLC) follo...
FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy
FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy
AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most sub...
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