Approved a new initial treatment for advanced non-small-cell lung cancer after clinical trials showed patients lived longer without disease progression, compared to the standard treatment currently used. The chemotherapy-free combination involves two drugs, one of which has never been approved for use in the U.S. called lazertinib, which will be...

FDA Approves New Treatment for Non-Small-Cell Lung Cancer

ATR-04 is currently being developed to treat dermal toxicity from epidermal growth factor receptor inhibitor cancer therapy. The phase 1/2 trial will commence in late 2024. The FDA has cleared an investigational new drug application for a first-in-human phase 1/2 study of ATR-04 for moderate to severe dermal toxicity from epidermal growth factor receptor inhibitors, Azitra Inc. announced in a press release.

FDA clears development of drug to treat cancer therapy-induced skin rash

GSK plc (. GSK - Free Report) announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed/refractory extensive-stage small-cell lung cancer (ES-SCLC). The FDA grants Breakthrough Therapy designation to expedite the development and review of...

GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag

T-DXd receives FDA breakthrough therapy designation for HR+/HER2-low breast cancer and real-world data confirms brexu-cel’s efficacy in relapsed/refractory B-cell ALL. A New AI-based study enrolls first patient, strengths and weakness in multiple myeloma treatment are examined, and tafasitamab combination scores in FL. Want to test your knowledge on the...

The Targeted Pulse: T-Dxd Received FDA Breakthrough Therapy Designation, Real-World Data Confirms Brexu-cel’s Impact, and More

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy. Opaganib, a proprietary and investigational host-directed drug developed by Tel Aviv-based RedHill Biopharma, has been given orphan drug designation by FDA for treatment of neuroblastoma, a type of cancer that is the most common malignancy among infants, with a median age of 17 months at the time of diagnosis (1). RedHill announced the FDA decision in a press release on Aug. 26, 2024.

FDA Grants Orphan Drug Designation to RedHill’s Treatment for Neuroblastoma

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments. In a report published last week...

FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

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NewsNinja

‘Any meat items my dogs refuse to eat, I no longer eat.’ It’s said that animals have a “sixth sense,” which affords them an insight human beings cannot match. There are clips of security camera earthquake footage where pets can be seen wigging out seconds before tremors begin.

‘It ain’t food anymore.’: Dairy Queen customer warns against chicken after his dog refuses to eat it

Coffee County, GA

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

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Daily Coffee Press

Last week, two individuals from Coffee County were charged with trafficking methamphetamine following a search at a residence on Willacoochee Highway. On August 13, detectives with the Coffee County Drug Unit conducted an operation involving Charles Black, which led to a search of his residence on Willacoochee Highway. According to the report, Black left his residence before the warrant was served and was subsequently detained.

Two Charged with Trafficking Methamphetamine After Search in Coffee County

Tampa, FL

Questions about multiple myeloma regarding treatment options, bone strength and other associated comorbidities were answered by an expert. Multiple myeloma is a rarer disease than other cancers, such as lung or breast cancer, an expert told CURE®. During the CURE® Educated Patient® Multiple Myeloma Summit, patients asked some questions about the disease.

Multiple Myeloma: 8 Frequently Asked Patient Questions

The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects in the knee. The FDA has approved Vericel Corporation’s MACI for repairing cartilage defects in the knee. According to the company, MACI uses a patient’s own cells cultured on a porcine collagen membrane. This method, also known as MACI Arthro, can be administered through small incisions using custom instruments, providing a substantial improvement in full-thickness cartilage defects up to 4 cm² in size, offering a less invasive option, according to the company.1.

FDA Approves Arthroscopic Delivery of Vericel’s MACI for Knee Cartilage Defects

Ozempic and Wegovy may have some new competition. Eli Lilly has announced that its new diabetes drug, Zepbound (tirzepatide), reduced the risk of developing Type 2 diabetes by 94% in prediabetic adults in a clinical trial. Additionally, treatment with tirzepatide resulted in sustained weight loss through the treatment period, with...

Eli Lilly says its new diabetes drug was 94% effective in clinical trials

SurvivorNet

When it comes to treating non-Hodgkin lymphoma, bispecific antibodies are a unique targeted therapy that essentially attack cancer on two fronts — and recent approvals mean more patients have access.

Bispecific Antibodies for Lymphoma: What Does the Future Look Like for the Promising Targeted Therapy?

Georgia State

Appling County, GA

A 40-year-old man from Appling County, Christopher Eric Stone, with a significant criminal history, was recently sentenced to over five years in prison after pleading guilty to possession of methamphetamine with intent to distribute, according to officials from the Department of Justice.

Georgia Man Sentenced to Over 5 Years for in Federal Prison for Meth Distribution

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training. Roche’s PiaSky (crovalimab) has been approved by the European Commission (EC) for certain patients with paroxysmal nocturnal hemoglobinuria (PNH), Roche announced in a press...

Paroxysmal Nocturnal Hemoglobinuria Treatment from Roche is Approved in EU

Alzheimer’s disease research and drug development is evolving at a rapid pace. Decades of research has led to the approval of the first disease-modifying drugs and new pathological discoveries. The first blood-based biomarker tests will bring equitable access to screening and diagnosis while accelerating clinical research. These major breakthroughs in the last few years alone represent a pivotal time in the Alzheimer’s disease landscape.

The Evolving Alzheimer’s Disease Landscape

According to officials with the Southern District of Georgia, two recently unsealed federal indictments have charged 23 defendants in a series of broad conspiracies involving the use of drones to smuggle methamphetamine, marijuana, and cell phones into state prisons in Georgia.

23 Defendants Charged in Federal Indictments for Drone-Smuggling Drug Operation in Georgia

The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH. FDA announced in a press release on Aug. 9, 2024 that itapproved Yorvipath (palopegteriparatide), an Ascendis Pharma product, for administration by subcutaneous injection to adults with hypoparathyroidism (1).

FDA Approves New Drug for Rare Disorder Hypoparathyroidism

People are excited to use semaglutide, a diabetes drug popular for assisting weight loss that's commonly sold as Ozempic and Wegovy — and there's good reason to be. But the Food and Drug Administration is now warning the public not to get carried away, issuing an alert that it's received reports of people getting hospitalized after overdosing on the drug, in some cases taking up to 20 times the recommended dosage.

FDA Says People Are Taking 20 Times the Proper Dose of Ozempic and Overdosing

Florida State

Jacksonville, FL

Jacksonville Today

Jacksonville Sheriff T.K. Waters said he will consider more DUI patrols if voters legalize recreational marijuana use in Florida. Voters will consider Amendment 3 in November. It would allow adults 21 or older to possess, purchase or use marijuana products and marijuana accessories for non-medical purposes.

More DUI patrols possible if marijuana issue passes

NewsBreak

GSK’227 Gets FDA Breakthrough Therapy Designation for ES-SCLC

The antibody-drug conjugate GSK’227 is intended to treat patients with extensive-stage small cell lung cancer. The Food and Drug Administration (FDA) has granted breakthrough therapy designation...

GSK’227 Gets FDA Breakthrough Therapy Designation for ES-SCLC

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