United States Food and Drug Administration
Biogen’s Leqembi Gains Momentum: A Steady Pace in Market Growth
Biogen, Leqembi, Alzheimer’s disease, clinical trials, FDA approval, market growth, steady pace, neurology, healthcare, pharmaceuticals.
FDA Fast-Tracks Day One’s Innovative Therapy for Pediatric Brain Tumors
FDA, accelerated approval, Day One, targeted treatment, pediatric brain tumors, glioma, children, cancer treatment, innovative therapy.
Day One Outshines Novartis: FDA Approves Ojemda for Wider Pediatric Brain Tumor Treatment
Day One, Novartis, FDA, Ojemda, pediatric brain tumor, cancer treatment, clinical trials, pharmaceutical industry.
FDA Rejects Abeona’s PZ-CEL Topical Gene Therapy, Delaying Further Progress
Abeona, PZ-CEL, topical gene therapy, FDA, rejection, delay, clinical trials, EB-101, Epidermolysis Bullosa
ImmunityBio’s Anktiva Receives FDA Approval, Set to Rival Merck in Bladder Cancer Treatment
ImmunityBio, Anktiva, FDA approval, bladder cancer, Merck, cancer treatment, Patrick Soon-Shiong.
FDA Grants Approval to ImmunityBio’s Innovative Combination Therapy for Bladder Cancer
FDA, ImmunityBio, bladder cancer, combination therapy, approval, innovative treatment, immunotherapy, clinical trials
FDA Issues Complete Response Letter to Abeona’s Cell Therapy for Rare Skin Disease
FDA, Complete Response Letter (CRL), Abeona, cell therapy, rare skin disease, Epidermolysis Bullosa (EB)
ImmunityBio’s Innovative IL-15 Superagonist Receives FDA Approval for Non-Muscle Invasive Bladder Cancer Treatment
ImmunityBio, FDA Approval, IL-15 Superagonist, Non-Muscle Invasive Bladder Cancer (NMIBC), Immunotherapy, Cancer Treatment
FDA Approves Takeda’s Subcutaneous Entyvio Injection for Maintenance Therapy in Moderate to Severe Crohn’s Disease
FDA, Takeda, Entyvio, Subcutaneous, Injection, Maintenance Therapy, Crohn’s Disease
Roche’s Alecensa Gains FDA Approval for Postsurgical Early Lung Cancer Treatment
Roche, Alecensa, FDA approval, Postsurgical treatment, Early lung cancer