FDA

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...

Evaluating the Series of Infant Formula Recalls in the US

by Veronica Salib

Infant formula plays a critical role in pediatric healthcare, providing an alternate route for nutrition in babies who do not breastfeed or may need more nutrients than what is provided in breast milk. Although many people, including...

FDA Investigates the Safety of GLP-1 Weight Loss Drugs

by Veronica Salib

Yesterday, on January 11, 2024, the United States FDA issued a drug safety communication updating the public on an ongoing investigation of glucagon-like peptide-1 receptor agonists. The administration...

FDA Recalls 3 IV Drugs from Leiters Health for Potential Superpotency

by Veronica Salib

On January 5, 2024, the United States FDA published an announcement detailing a voluntary recall of multiple intravenous (IV) drugs manufactured by Leiters Health. The release notes that 33 lots of IV...

Navigating the Complex Terrain of Influenza Vaccine Strain Selection

by Alivia Kaylor

In the battle against influenza, the annual selection of vaccine strains is a crucial step in ensuring the effectiveness of flu vaccines. The process involves an intricate dance of global surveillance, scientific analysis, and regulatory...

AllianceRx Walgreens Selected to Distribute XDEMVY

by Alivia Kaylor

AllianceRx Walgreens Pharmacy, a leading specialty and home delivery pharmacy in the United States and a subsidiary of Walgreens, has been selected as one of four specialty pharmacies to distribute...

FDA Launches New Advisory Committee for Genetic Metabolic Diseases

by Veronica Salib

Adding to the lengthy list of advisory committees under its belt, the United States Food and Drug Administration (FDA) announced its plans to create a new advisory committee to specialize in genetic...

FDA Approves First CRISPR-Based Gene Therapy

by Veronica Salib

Last week marked a monumental regulatory decision for CRISPR-based gene editing technologies. The United States Food and Drug Administration (FDA) approved the first two cell-based gene therapies for...

FDA Publishes Drug Safety Communication for Antiseizure Drugs

by Veronica Salib

Earlier this week, the United States Food and Drug Administration (FDA) published a drug safety communication warning patients about potentially life-threatening side effects linked to levetiracetam...

Biden Leverages DPA to Strengthen Pharmaceutical Supply Chain

by Veronica Salib

On Monday, November 27, 2023, the White House released a fact sheet from the Biden administration outlining plans to strengthen domestic supply chains, reduce consumer costs, and secure key supply...

Ensuring Equal Clinical Trial Access Across Vulnerable Communities

by Editorial Staff

Clinical trials play a critical role in ensuring the widespread safety of medical products for patients by analyzing product efficacy, safety, and indications. Since clinical trial data is used to guide drug approvals and standards of care...

FDA Announces Kilitch Healthcare India Eyedrop Recall

by Veronica Salib

On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through...

FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

by Veronica Salib

On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven...

What to Know About the 2023 Eyedrop Recalls, Understanding the Risks

by Veronica Salib

On February 2, 2023, the first of three eyedrops in the United States were recalled voluntarily after multiple reports of illness associated with the drops were reported to the CDC. Since then, two additional eye drops in the US...

Sage Therapeutics Announces Wholesale Cost of Zuranolone, $15,900

by Veronica Salib

On November 7, 2023, Sage Therapeutics, the manufacturer of ZURZUVAE (zuranolone), announced that the wholesale acquisition cost of the postpartum depression drug would be $15,900 for a 14-day...

8 Steps to Negotiating Successful Pharmaceutical Partnerships

by Alivia Kaylor

The pharmaceutical industry is a dynamic and highly regulated sector that offers immense potential for healthcare technology companies seeking collaborative opportunities. By forging strategic partnerships with pharmaceutical companies,...

Researchers Reveal Positive Data on New Antibiotic for Super Gonorrhea

by Veronica Salib

On November 1, 2023, the Global Antibiotic Research and Development Partners (GARDP) and Innoviva Specialty Therapeutics, a subset of Innoviva Inc, issued a co-authored press release announcing that a...

26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

by Veronica Salib

On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health,...

Understanding the Dangers of Nutraceuticals and Dietary Supplements

by Veronica Salib

Throughout the past few decades, the healthcare industry has seen the emergence of a new class of treatments: nutraceuticals. A cross between nutrition and pharmaceuticals, the term nutraceutical was coined by Stephen DeFelice, MD, in...