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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...
Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating ELX-02 for the Treatment of Alport Syndrome
Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating ELX-02 for the Treatment of Alport Syndrome
Eloxx Pharmaceuticals, Inc., a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the first patients have now been enrolled in its Phase 2 study of ELX-02 fo...
Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate
Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate
The FDA granted Syros Pharmaceuticals Fast Track status for its drug candidate tamibarotene for the treatment of higher-risk myelodysplastic syndrome, a group of disorders caused by a disruption i...
US FDA clears Transcenta’s IND for Rett syndrome treatment
US FDA clears Transcenta’s IND for Rett syndrome treatment
The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome....
Lilly injects $450m into plant making Mounjaro
Lilly injects $450m into plant making Mounjaro
Eli Lilly is leaving nothing to chance when it comes to making the most of its fast-growing diabetes therapy Mounjaro – it is investing another $450million at a facility in North Carolina that wi...
FDA Expands Sources for Cannabis Clinical Research
FDA Expands Sources for Cannabis Clinical Research
The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis.
TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor
TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor
TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.  ...
Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug
Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug
Takeda will pay Hutchmed $400 million upfront to license an experimental cancer drug for use outside of China, with plans to complete a submission for U.S. approval in the first half of the year. ...
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