Intellectual Product – Page 19

Zilovertamab Vedotin, Antibody-Drug Conjugate (ADC), Diffuse Large B-Cell Lymphoma (DLBCL), Phase 2 Trial, Phase 3 Trial, ROR1, Merck, waveLINE Program

FDA Action Alert: Recent Developments on Unapproved Drugs and Prescription Drug Approvals

7 months ago talkbio0Tagged approvals, Azurity, Clinical action, Ionis, lexicon, Myers, Prescription procedure, squibb, unapproved, United States Food and Drug Administration

FDA Action Alert, Unapproved Drugs, Prescription Drug Approvals, Azurity Pharmaceuticals Inc., Bristol Myers Squibb, Ionis, Lexicon

Trump’s Re-Election: A Mixed Bag for Biopharma with M&A Upsides and Vaccine Concerns

7 months ago talkbio0Tagged Acquisitions, Administration occupational activities, Biopharma, Independence, Inflation, mergers, Policy, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vaccines

Trump Administration, Biopharma, Mergers and Acquisitions, Vaccine Policy, Robert F. Kennedy Jr., FDA Independence, Inflation Reduction Act

FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

7 months ago talkbio0Tagged ADRIATIC, Approved, Breakthrough Therapy, durvalumab, Identifier, Imfinzi, Limited-stage, LS-SCLC, Phase 3 Clinical Trials, Priority Review, Systemic Immunotherapy, United States Food and Drug Administration

Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review

Pragmatic Clinical Trials: Bridging the Gap Between Research and Real-World Practice

8 months ago talkbio0Tagged Clinical Trial Design, Effectiveness, Evidence, Healthcare decision making, Pragmatic Clinical Trials as Topic, Real-world, research

1. Pragmatic Clinical Trials, 2. Real-World Evidence, 3. Clinical Trial Design, 4. Effectiveness Research, 5. Healthcare Decision Making

Outlook Therapeutics to Resubmit BLA for ONS-5010 Despite Missing Primary Endpoint in NORSE EIGHT Trial

8 months ago talkbio0Tagged AMD, Approved, Attitude, Biologics License Application, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, United States Food and Drug Administration, Wet Age-Related Macular Degeneration

Outlook Therapeutics, ONS-5010, Lytenava, Wet Age-Related Macular Degeneration (wet AMD), Biologics License Application (BLA), NORSE EIGHT Trial, FDA Approval