FDA

Stop Clopez Corp voluntarily recalls herbal dietary supplement

April 26, 2024 - On April 23, 2024, the United States FDA published a voluntary recall from Stop Clopex Corp regarding its Schwinnng capsules. According to the recall, the product was found to contain Nortadalafil, an active drug ingredient, during an FDA analysis. Dietary supplements are only loosely regulated across the United States. Unlike pharmaceutical...

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Evaluating the safety profile of mifepristone

by Alivia Kaylor

Mifepristone, commonly known as the abortion pill, is a medication used primarily for medically induced abortions as well as the management of Cushing's syndrome and uterine leiomyomas. Since its approval in 2000, mifepristone has been...

CDC, FDA investigate harmful counterfeit Botox

by Veronica Salib

On April 15, 2024, the United States Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) launched an investigation into harmful reactions caused by counterfeit or...

Heart devices linked to injuries, deaths receive FDA’s most serious recall

by Alivia Kaylor

In a recent announcement, the Food and Drug Administration (FDA) revealed that a pair of heart devices, the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), has received the agency's most serious recall...

CRN launches new labeling guidelines for melatonin supplements

by Veronica Salib

On April 15, 2024, the Council for Responsible Nutrition (CRN), one of the most prominent trade associations for the dietary supplements industry, issued a statement highlighting new labeling...

Exploring 5 types of intellectual property protections in pharma

by Veronica Salib

The Journal of Advanced Pharmaceutical Technology & Research defines intellectual property as “any original creation of the human intellect such as artistic, literary, technical, or scientific creation.” Intellectual...

Abbott provided $650,000 to FDA advisory panel members

by Veronica Salib

How should regulatory bodies and consumers weigh payments made by life sciences companies to FDA advisory panel members? That’s the question posed by the recent news that 10 of 14 voting members...

Walgreens Specialty Pharmacy leads RVVC care with VIVJOA exclusivity

by Alivia Kaylor

In a move set to revolutionize treatment options for post-menopausal women and those not of reproductive potential, Walgreens specialty pharmacy patients now have exclusive access to VIVJOA, an...

Drawbridge Health’s NanoDrop gains FDA clearance for at-home blood sampling

by Alivia Kaylor

Drawbridge Health, a pioneering healthcare technology company, announced an innovative achievement today as its advanced at-home blood sampling device, NanoDrop Lancet, received United States Food and...

FDA issues warning letters for unapproved topical pain relief products

by Veronica Salib

On March 26, 2024, the United States FDA published a press release informing consumers of six warning letters sent to companies regarding unauthorized topical pain relief products. The following...

SCOTUS to issue a decision on mifepristone in the coming months

by Veronica Salib

The Supreme Court of the United States (SCOTUS) has yet to decide on mifepristone access in the US; however, many predict that the decision will come by late spring, June or July 2024 at the latest....

FDA ODAC favors 2 CAR T-cell therapies for multiple myeloma

by Veronica Salib

A meeting of the United States FDA Oncologic Drugs Advisory Committee (ODAC) voted to expand the approval of Abecma and Carvykti, two types of chimeric antigen receptor (CAR) T-cell therapies, for...

FDA requests $7.2 billion from Biden’s 2025 fiscal year budget

by Veronica Salib

On March 11, 2024, the United States FDA issued a press release announcing its request for $7.2 billion from the president’s fiscal year (FY) 2025 budget, increasing its FY 2023 request by 7.4%...

FDA expands Wegovy indications, adding cardiovascular disease

by Veronica Salib

On March 8, 2024, the United States FDA expanded approval of Wegovy (semaglutide), making it the first weight loss drug that is FDA-approved for obese and overweight patients at high risk for heart...

FDA Approves New First-Line Treatment for Pancreatic Adenocarcinoma

by Veronica Salib

Adding to existing pancreatic cancer treatment options, the United States FDA granted Ipsen Biopharmaceuticals approval for Onivyde — generically known as irinotecan liposome — for treating...

Gilead Announced Plans to Acquire CymaBay in a $4.3 Billion Deal

by Veronica Salib

On Monday, February 12, 2024, Gilead Sciences, a major pharmaceutical manufacturer, announced its plans to acquire CymaBay Therapeutics, a clinical-stage biopharmaceutical company with a strong liver...

GLP-1 Receptor Agonists Reduce 24-Hour Ambulatory Blood Pressure

by Veronica Salib

On Monday, February 5, 2024, a research letter published in Hypertension highlighted the benefit of tirzepatide in managing high blood pressure using data from the SURMOUNT study. The letter notes a...

Comparing Female Fertility Drugs: Use Cases, Effectiveness, Risks

by Veronica Salib

Infertility, or the inability to conceive, is characterized by one year of unprotected sex without a subsequent pregnancy. Although infertility can result from male or female partners, most available fertility drugs work on addressing...

Mislabeled Packaging Results in Recalled ADHD Medication

by Veronica Salib

On January 24, 2024, Azurity Pharmaceuticals sent an announcement to the United States FDA recalling Zenzedi, a brand name for 30 mg dextroamphetamine sulfate tablets, for mislabeled packaging. The...

Exploring and Managing GLP-1 Receptor Agonists in Weight Loss

by Veronica Salib

Over the past few years, weight loss drugs like Ozempic and Wegovy have received extensive attention in mainstream media for their weight loss effects. Beyond attention from the general public, this class of medications, the glucagon-like...

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