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Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – November 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – October 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions - September 2024

Upcoming FDA Decisions – September 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

What's Changed & Predictions Gout

Gout – What’s Changed Since+ Predictions

Gout is a common medical condition characterized by the accumulation of monosodium urate (MSU) monohydrate crystals in the tissues, often resulting in painful flares that can last for one to two weeks. According to the National Institutes of Health (NIH), gout is more prevalent in men than in women and typically presents in middle age. […]

What's Changed & Predictions Hyperlipidemia

Pharmacological Management for Hyperlipidemia – What’s Changed Since+ Predictions

High cholesterol, also known as hyperlipidemia, affects millions of individuals in the United States (US). This condition can lead to serious health issues, such as an increased risk of heart disease and stroke. Globally, approximately one-third of cases of ischaemic heart disease are linked to high cholesterol levels. Elevated total cholesterol is a significant contributor […]

Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – August 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

What's Changed & Predictions Treatment of Patients With Schizophrenia

Treatment of Patients With Schizophrenia – What’s Changed Since+ Predictions Series

Among the top 10 causes of disability worldwide, schizophrenia’s relatively low prevalence is starkly contrasted by its profound impact on functional capacity and quality of life. With the National Institute of Mental Health estimating its prevalence in the US to range between 0.25% and 0.64%, schizophrenia is a disproportionately significant contributor to the global burden […]

Upcoming FDA Approvals & Decisions - July 2024

Upcoming FDA Decisions – July 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Guidelines Rundown Multiple Myeloma

What’s New in Multiple Myeloma Guidelines – Guidelines Rundown

Multiple Myeloma, also known as Myeloma or Plasma Cell Myeloma, is a type of cancer that affects plasma cells, which are responsible for producing antibodies to protect against infections. This disease can present in various ways, ranging from a slow-developing form with minimal protein abnormalities and few malignant cells to a rapidly progressing and life-threatening […]

Upcoming FDA Approvals & Decisions - June 2024

Upcoming FDA Decisions – June 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Decisions – May 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug or device applications. Below, you will find a list of drugs and devices, […]

New FDA Medication Approval – Anktiva for NMIBC

On April 22, 2024, the US Food and Drug Administration (FDA) approved ImmunityBio’s first-in-class interleukin-15 superagonist (IL-15) nogapendekin alfa inbakicept-pmln (Anktiva), plus bacillus Calmette-Guérin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.  Designated an FDA Breakthrough Therapy, the novel immunotherapy […]

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New Clinical Practice Guidelines & FDA Drug Approvals – September 2023

Management of Endometrial Intraepithelial Neoplasia or Atypical Endometrial Hyperplasia Author:American College of Obstetricians and Gynecologists (ACOG) Published:September 1, 2023 Outpatient Treatment of Confirmed COVID-19 Author:American College of Physicians (ACP) Published:September 19, 2023 Optimal Timing of Elective Hip or Knee Arthroplasty for Patients with Symptomatic Moderate to Severe Osteoarthritis or Advanced Symptomatic Osteonecrosis with Secondary Arthritis […]

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New Clinical Practice Guidelines & FDA Drug Approvals – August 2023

Folic Acid Supplementation to Prevent Neural Tube Defects: Preventive Medication Author:United States Preventive Services Task Force (USPSTF) Published:August 2023 Prevention of Acquisition of HIV: Preexposure Prophylaxis Author:United States Preventive Services Task Force (USPSTF) Published:August 2023 Palliative Care for People with Chronic Obstructive Pulmonary Disease or Interstitial Lung Disease Author:European Respiratory Society (ERS) Published:August 17, 2023 […]

New Clinical Practice Guidelines & FDA Drug Approvals – July 2023

Lipid Disorders in Children and Adolescents: Screening Author:United States Preventive Services Task Force (USPSTF) Published:July 2023 Implementing Strategies to Prevent Infections in Acute-Care Settings Author:Infectious Diseases Society of America (IDSA); Society for Healthcare Epidemiology of America America (SHEA) Published:July 11, 2023 Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy Author:American Society of Clinical Oncology (ASCO) […]

New Clinical Practice Guidelines & FDA Drug Approvals – June 2023

Anxiety Disorders in Adults: Screening – Adults 64 Years or Younger Author:United States Preventive Services Task Force (USPSTF) Published:June 2023 Anxiety Disorders in Adults: Screening – Older Adults 65 Years or Older Author:United States Preventive Services Task Force (USPSTF) Published:June 2023 Depression and Suicide Risk in Adults: Screening – Adults 64 Years or Younger Author:United […]

New Clinical Practice Guidelines & FDA Drug Approvals – May 2023

Addressing Stigma and Bias in the Diagnosis and Management of Patients with Obesity/Adiposity-Based Chronic Disease and Assessing Bias and Stigmatization as Determinants of Disease Severity Society:American Association of Clinical Endocrinologists (AACE) Published:May 4, 2023 Health Advisory on Social Media Use in Adolescence Society:American Psychological Association (APA) Published:May 9, 2023 2023 Comprehensive Type 2 Diabetes Management […]

New Clinical Guidelines & FDA Drug Approvals – April 2023

Skin Cancer: Screening Society:U.S. Preventative Services Task Foce (USPSTF) Published:April 18, 2023 COVID-19 Guideline Part 1: Treatment and Management Society:Infectious Diseases Society of America (IDSA) Published:April 13, 2023 Use of Antiretroviral Agents in Pediatric HIV Infection Society:United States Department of Health and Human Services (DHHS) Published:April 12, 2023 Management of REM Sleep Behavior Disorder Society:American […]