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- Recognizing and Reporting Potentially False or Misleading Prescription Drug Promotion with Dr. Catherine Gray
Q&A with FDA: Recognizing and Reporting Potentially False or Misleading Prescription Drug Promotion with Dr. Catherine Gray
- Understanding Drug Recalls with Dr. Ileana Elder
In this episode of the Q&A with FDA podcast, learn about Understanding Drug Recalls with Dr. Ileana Elder in the Office of Compliance.
- Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim
In this episode of the Q&A with FDA podcast, learn about Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim from FDA’s Office of Generic Drugs.
- Real-World Data and Evidence Generation with Dr. Hilary Marston
In this episode of the Q&A with FDA podcast, learn about real world evidence, real world data, and how FDA continues to advance clinical trials and promote reliable evidence to support the safety and effectiveness of drug products with Dr. Hilary Marston, FDA’s Chief Medical Officer.
- The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad
Listen to a soundcast of the May 8, 2024, Q&A with FDA: The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients
Listen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
Listen to a soundcast of the 8.2.2024 FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma
Listen to a soundcast of the 9.17.2024 FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma.
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer
Listen to a soundcast of the June 13, 2024, and June 21, 2024, Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer.
- Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
- FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.
- FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
- Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.
- FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).