FDA Approvals

CDC, FDA investigate harmful counterfeit Botox

April 19, 2024 - 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 mishandled botulinum toxin (Botox). According to a CDC outbreak investigation report, as of April 12, 2024, 19 reported illnesses caused by Botox...

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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 approves $4.25 million gene therapy for MLD

by Veronica Salib

Once again, the pharmaceutical industry has topped its existing astronomical prices with Lenmeldy, an FDA-approved gene therapy for children with pre-symptomatic late infantile, pre-symptomatic early...

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...

Senate Hearing Challenges Pharma CEOs on Drug Pricing

by Alivia Kaylor

In a heated Senate hearing on February 8th, the CEOs of Bristol Myers Squibb, Johnson & Johnson, and Merck faced rigorous questioning from various United States senators regarding the exorbitant...

Breaking Down the Cost of Sickle Cell Disease Gene Therapies

by Veronica Salib

Earlier this week, the Biden–Harris administration announced its plans to address the expensive price tag of sickle cell disease, looking for a way to widen access despite the cost. In an...

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 Approves First Therapy for Progressing Desmoid Tumors

by Veronica Salib

On Monday, November 27, 2023, the United States Food and Drug Administration (FDA) approved Ogsiveo (nirogacestat), making it the first FDA-approved treatment for desmoid tumors. The drug is intended...

FDA Approves Truqap, Faslodex for HR-Positive Breast Cancer

by Veronica Salib

On November 16, 2023, the United States Food and Drug Administration approved AstraZeneca’s Truqap (capivasertib) to be administered in combination with fulvestrant for adults with hormone...

FDA Approves New Weight Loss Drug: Zepbound

by Veronica Salib

On November 8, 2023, the United States Food and Drug Administration (FDA) approved Eli Lilly’s newest weight loss drug, Zepbound. The newly approved drug uses the same active ingredient as...

CDC Urges Rationing of New Antibody Shot for Infant RSV Protection

by Alivia Kaylor

In response to the overwhelming demand for the newly approved antibody shot, Beyfortus, designed to safeguard newborns from respiratory syncytial virus (RSV), the Centers for Disease Control and...

FDA Reviews AstraZeneca’s Self-Administered Flu Vaccine, FluMist

by Alivia Kaylor

In a landmark development in the world of healthcare, AstraZeneca's FluMist Quadrivalent is set to revolutionize flu vaccination by potentially becoming the first and only self-administered flu...

FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain

by Veronica Salib

Earlier this week, Hyloris Pharmaceuticals, a pharmaceutical company headquartered in Belgium, announced the approval of a potent non-opioid painkiller in the United States. The US Food and Drug...

Ensuring Drug Safety Through Regulatory Compliance

by Alivia Kaylor

In healthcare technology, the intersection of science and regulations is where innovation meets responsibility. Nowhere is this more evident than in the pharmaceutical industry, where drug safety is paramount. Regulatory compliance plays a...

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