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Landmark Federal Data Privacy Proposal Unveiled
Federal Data Privacy, Public Showcase, Proposal, Consumer Rights, Privacy Law
Alecensa: FDA-Approved First ALK Inhibitor for Adjuvant Treatment in Early-Stage ALK-Positive NSCLC
Alecensa, ALK Inhibitor, Adjuvant Treatment, Early-Stage ALK-Positive NSCLC, FDA Approval, Genentech, Roche Group, ALINA Study, 76% Reduction in Disease Recurrence or Death, NCCN Guidelines
Fujifilm Diosynth’s Restructuring Plan May Leave 240 Employees Jobless
Fujifilm Diosynth, CDMO (Contract Development and Manufacturing Organization), Restructuring plan, Potential job loss, 240 staffers
Roche’s Ocrevus Demonstrates Near-Complete Reduction of Relapse and Lesions in Multiple Sclerosis
Ocrevus, Roche, Multiple Sclerosis (MS), Relapse reduction, Lesion reduction, Clinical and MRI measures
Eli Lilly’s Zepbound Shows Promising Results in Reducing Sleep Apnea Severity in Pivotal Trials
Eli Lilly, Zepbound, Sleep Apnea, Obstructive Sleep Apnea (OSA), Pivotal Trials, Obesity, GLP-1 Receptor Agonist, Tirzepatide, CPAP, Weight Loss
Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing
Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing
Neumora Therapeutics’ Schizophrenia Drug NMRA-266 Faces FDA Hold Over Convulsions in Rabbits
Neumora, United States Food and Drug Administration, NMRA-266, Seizures, Schizophrenia
EU Regulators Confirm No Link Between GLP-1 Drugs and Suicidal Thoughts
GLP-1 drugs, Ozempic, Wegovy, European Medicines Agency (EMA), No link to suicidal thoughts, Investigation
AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11
AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11
Enhanced Optimization for Influenza B Strains Planned in CureVac’s mRNA Seasonal Flu Vaccine Trials
CureVac, mRNA flu vaccine, Influenza B strains, Targeted optimization, Phase 2 studies, Multivalent candidate, Improved immune response, Collaboration with GSK