Diana Ernst, Monthly Prescribing Reference Journalist Profile

Articles

RFK Jr Selects 8 New Members for CDC’s Vaccine Advisory Panel

1 week ago | endocrinologyadvisor.com | Diana Ernst

The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr named 8 new members to the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) following the removal of the 17 sitting members this week. The announcement, which was made on X, lists the 8 new members and their credentials. They include Joseph R.
FDA Drug Approval Decisions Expected in July 2025

1 week ago | rheumatologyadvisor.com | Diana Ernst

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
FDA Drug Approval Decisions Expected in July 2025

1 week ago | dermatologyadvisor.com | Diana Ernst

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
Keytruda Gains HNSCC Indication for Perioperative Treatment

2 weeks ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 (PD-L1) (combined positive score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
Contaminated Cotton Swabs Prompt Recall of 3 Over-the-Counter Products

2 weeks ago | infectiousdiseaseadvisor.com | Diana Ernst

Church & Dwight Co, Inc has initiated a recall of all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs due to potential microbial contamination.
Drug-Device Combo Therapy Under Review for Parkinson Disease

2 weeks ago | neurologyadvisor.com | Diana Ernst

The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for ND0612 for the treatment of motor fluctuations in patients with Parkinson disease. ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution.
Keytruda Approved as Perioperative Treatment for HNSCC

2 weeks ago | cancertherapyadvisor.com | Diana Ernst

The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1), as determined by an FDA-approved test.
Widaplik, a Single Pill, Triple Combo Therapy for Hypertension, Gets FDA Approval

2 weeks ago | thecardiologyadvisor.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Widaplik™ (telmisartan, amlodipine and indapamide), a single pill combination therapy, for the treatment of hypertension, including as initial treatment, to lower blood pressure (BP). Widaplik consists of 3 active ingredients with separate mechanisms involved in BP regulation: telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic.
RFK Jr Selects 8 New Members for CDC’s Vaccine Advisory Panel

2 weeks ago | empr.com | Diana Ernst

The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr named 8 new members to the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) following the removal of the 17 sitting members this week. The announcement, which was made on X, lists the 8 new members and their credentials. They include Joseph R.
Ibtrozi Approved for Advanced ROS1-Positive NSCLC

2 weeks ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib, a tyrosine kinase inhibitor (TKI), is designed to inhibit the growth of cancer cells expressing ROS1 fusion genes and mutations.