Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial
Roche; oral SERD; giredestrant; progression-free survival; pivotal study; breast cancer; ER-positive; endocrine therapy; Phase III trial; advanced breast cancer
AstraZeneca and SOPHiA GENETICS Expand AI-Powered Cancer Testing Collaboration
AstraZeneca; SOPHiA GENETICS; AI; cancer testing; breast cancer; prostate cancer; next generation sequencing (NGS); PIK3CA/AKT1/PTEN pathway; real-world evidence; precision medicine
Parkinson’s Patients Prefer Medtronic’s Adaptive Brain Stimulation Over Traditional Settings, Major Study Shows
Parkinson’s disease; adaptive deep brain stimulation; aDBS; Medtronic; ADAPT-PD study; FDA approval; DBS; personalized neuromodulation; real-time brain monitoring
FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval
CDC Advisors Shift COVID-19 Vaccine Guidance to Individual Decision-Making
CDC; COVID-19 vaccine; vaccine recommendation; individual choice; ACIP; provider consultation
FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial
Big Pharma-Backed MapLight Plots IPO to Advance Neuro Pipeline
MapLight Therapeutics; IPO; neuro pipeline; Alzheimer’s disease psychosis; schizophrenia; M1/M4 muscarinic agonist; Series D financing; Morgan Stanley; biopharmaceutical; clinical trials
Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review
Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review
Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach
Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy
Recent News: Gain Peace of Mind with the Lentiviral Experts
lentiviral vectors; CAR-T therapy; gene therapy; biologics; immuno-oncology; market growth; advanced manufacturing; regulatory approval