authorization
Leqembi wins EU authorization for some Alzheimer’s patients, giving Biogen, Eisai a boost over Lilly
Leqembi, EU, Eisai, Eli Lilly, ARIA, Biogen, authorization, Alzheimer, Kisunla, Restricted, Apolipoprotein E4, High
European Commission Revokes Marketing Authorization for Ocaliva, a Liver Disease Drug, Amid Regulatory Dispute
Ocaliva, European Commission, Marketing Authorization, Liver Disease, Primary Biliary Cholangitis (PBC), Advanz Pharma
FDA Authorizes LumiThera’s Valeda Light Delivery System for Dry AMD Treatment
FDA authorization, Valeda Light Delivery System, dry AMD treatment, photobiomodulation, LumiThera
European Court Suspends EC’s Decision to Revoke Ocaliva’s Marketing Authorization
Ocaliva, European Court, EC decision, marketing authorization, primary biliary cholangitis, PBC, Advanz Pharma
FDA Authorizes Novavax’s Updated COVID-19 Vaccine for Emergency Use
Novavax COVID-19 Vaccine, FDA Authorization, Emergency Use, Protein-Based Vaccine, JN.1 Variant
Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization
Novavax, COVID-19 vaccine, FDA, Emergency Use Authorization, protein-based vaccine, JN.1 variant
FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate
Invivyd, COVID-19, Pemgarda, Emergency Use Authorization, FDA, Immunocompromised, Variants
FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna for Enhanced Protection
COVID-19 vaccines, FDA approval, mRNA vaccines, Pfizer, Moderna, updated vaccines, KP.2 variant, JN.1 lineage, emergency use authorization, vaccination guidelines.
Biogen and Ionis’ ALS Treatment Qalsody Receives European Commission Approval
Biogen, Ionis, Qalsody, ALS, European Commission, Marketing Authorization, Rare Disease, SOD1-ALS, Neurofilament, Clinical Trials
Europe Temporarily Halts AstraZeneca’s Vaxzevria COVID-19 Vaccine on Company’s Request
AstraZeneca, Vaxzevria, COVID-19 vaccine, marketing authorization, suspension, Europe, European Medicines Agency (EMA), pharmacovigilance, safety concerns.