Submission
Pfizer and Valneva Report Strong Immune Responses from Second Lyme Disease Vaccine Booster
Lyme disease, vaccine, Pfizer, Valneva, VLA15, booster, immune response, Phase 2 trials, FDA submission
Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year
Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay
Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi
Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder
Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing
Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction