Qualitative Concept
FDA Clears BioNTech-MediLink ADC Trial to Resume with Reduced Doses
BioNTech, MediLink, ADC trial, FDA approval, lower doses, cancer treatment, HER3, patient safety
Embracing Agility: Critical for the Role of QARA Professional
QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.
FDA’s Rejection of Lykos’ MDMA-Assisted Therapy for PTSD: A Setback but Not a Roadblock for Psychedelic Research
MDMA, PTSD, Lykos Therapeutics, FDA rejection, psychedelic therapy, clinical trials, ethical violations, scientific integrity.
FDA Approves AstraZeneca’s Imfinzi for Use Before and After Lung Cancer Surgery
FDA approval, AstraZeneca, Imfinzi, lung cancer, surgery, neoadjuvant, adjuvant, durvalumab, NSCLC
FDA Approval of Amgen’s Imdelltra for Lung Cancer Amidst Challenges and Market Competition
Amgen, Imdelltra, FDA approval, lung cancer, bispecific T-cell engager, adverse events, Merck, Curon, Legend Biotech
Incyte Seeks Expanded Approval for Monjuvi Following Successful Phase III Trial in Follicular Lymphoma
Incyte, Monjuvi, follicular lymphoma, Phase III trial, label expansion, tafasitamab, MorphoSys, FDA approval, cancer treatment.
Incyte and Syndax Secure FDA Approval for Niktimvo, a Breakthrough Treatment for Chronic Graft-Versus-Host Disease
Incyte, Syndax, Niktimvo, FDA approval, graft-versus-host disease, GVHD, axatilimab-csfr, chronic GVHD, allogeneic stem cell transplant
Novo Nordisk’s Wegovy Approved in China: Implications and Future Challenges
Novo Nordisk, Wegovy, semaglutide, obesity treatment, China approval, generic competition, patent expiration, pharmaceutical market
Gilead’s $4.3B Acquisition of CymaBay Yields FDA Approval for Autoimmune Liver Disease Treatment
Gilead Sciences, CymaBay, FDA Approval, Autoimmune Liver Disease, Seladelpar, Primary Biliary Cholangitis
AstraZeneca Secures Landmark EU Approval for Imfinzi-Lynparza Combo in Endometrial Cancer Treatment
AstraZeneca, Imfinzi, Lynparza, endometrial cancer, EU approval, combination therapy, immunotherapy, PARP inhibitor, mismatch repair proficient, mismatch repair deficient