The FDA on Monday signed off on Liquidia Corporation’s Yutrepia (nebulized treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. However, the regulator’s tentative approval means that Yutrepia cannot yet enter the U.S. market—despite meeting all regulatory standards of safety, quality and efficacy.

Liquidia Misses Full Approval for Pulmonary Hypertension Drug as Competitor Retains Market Exclusivity

With an FDA approval in hand for primary biliary cholangitis (PBC) treatment Livdelzi (seladelpar), Gilead Sciences enters arenas that are both new and old. While the California drugmaker is launching an inflammatory drug for the first time, it also is familiar territory for the company as PBC is a liver disorder—which means that most of the physicians who prescribe medicines from Gilead’s blockbuster hepatitis portfolio are the same ones treating PBC patients.

With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's drug for types of lung disorders, and allowed only tentative clearances, sending its shares plummeting nearly 37% before the bell. The company said it has to wait for the expiration of regulatory exclusivity to United...

US FDA Delays Traditional Approval for Liquidia Corp's Inhaled Drug

Lykos Therapeutics is concluding a challenging week with a major reorganization, including laying off 75% of its staff. This drastic move follows a Food and Drug Administration (FDA) rejection and the retraction of three research papers on their MDMA treatment due to protocol violations at a clinical trial site. The company is also parting ways with its founder, Rick Doblin, in this significant shake-up.

Lykos Wraps Up Turbulent Week with 75% Staff Cuts Following FDA Rejection and Publication Retractions

Reuters

GDANSK (Reuters) - BioNTech on Monday said the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on an early stage study of its experimental cancer drug.

BioNTech says FDA lifts partial hold on its cancer drug trial

Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs. Amneal Pharmaceuticals Inc. announced yesterday the FDA approval for Parkinson’s drug Crexont (carbidopa and levodopa) via a news release on their website. This novel medication, formerly known as IPX203, combines two common drugs into one capsule.

FDA Approval Granted for Novel Parkinson’s Treatment

Kentucky State

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.

contributor

Northern Kentucky Tribune

The Kentucky Secretary of State on Friday announced 14,502 Kentuckians registered to vote in July. “Kentuckians are signing up to vote in big numbers, because they trust the integrity of our elections,” said Secretary of State Michael Adams.

Kentucky voter registrations increased by more than 14,500 in July, the most since 2022

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

The growing body of evidence that suggests that maintaining adequate levels of vitamin D may be beneficial for preventing and managing RVO. Vitamin D supplementation may play a critical role in preventing retinal vein occlusion (RVO),1 according to the investigators from the Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran.

Study suggests Vitamin D deficiency may increase risk of retinal vein occlusion

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases. This article was originally published on The Center for Biosimilars®. Sandoz secured another approval, this time for an aflibercept biosimilar.1 Enzeevu (aflibercept-abzv) is the fourth...

FDA Approves Biosimilar Enzeevu for Eye Conditions

A dose of Pfizer’s RSV vaccine was safe and generated a strong response in immunocompromised adults aged younger than 59 years. RSV vaccines have not been recommended for anybody aged younger than 60 years. A dose of Pfizer’s respiratory syncytial virus vaccine was well tolerated and generated a strong...

Pfizer: RSV vaccine generates strong response in immunocompromised adults

The Marijuana Herald

The Marijuana Herald - Marijuana news and information
A new study published in the Journal of Clinical Oncology reveals that marijuana capsules containing both tetrahydrocannabinol (THC) and cannabidiol (CBD) significantly reduces chemotherapy-induced nausea and vomiting in patients who have not responded to standard antiemetic treatments. This randomized, placebo-controlled, phase II/III trial, conducted across 19 hospitals and universities in Australia, is one of the … 
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The post Clinical Trial Finds Marijuana Capsules Effective in Reducing Chemotherapy-Induced Nausea and Vomiting appeared first on The Marijuana Herald.

Clinical Trial Finds Marijuana Capsules Effective in Reducing Chemotherapy-Induced Nausea and Vomiting

It’s important to communicate with the patient’s comanaging doctors to adjust necessary medications. There are four direct oral anticoagulants approved for atrial fibrillation and venous thromboembolism: apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa) and rivaroxaban (Xarelto). Click image to enlarge. The body is an interconnected system and, as clinicians...

Some Blood Thinners May Increase Conversion to Wet AMD

Among patients with fibromyalgia, there was a moderate negative correlation between vitamin D and physical functioning as well as between magnesium and stiffness. An exploratory study evaluating the link between specific micronutrients and the symptoms of fibromyalgia revealed vitamin D and magnesium played a role in physical function and stiffness among patients.1.

Vitamin D, Magnesium Deficiency Linked to Worse Fibromyalgia Symptoms

Colorado State

David Heitz

A bill quietly introduced this spring in the Colorado legislature to decriminalize the possession of drug paraphernalia obtained by harm reductionists has become law. As low-key as the legislation was introduced, the bill was signed into law without fanfare June 6. It garnered little to no media attention.

Colorado legalizes needles, pipes for meth and crack if obtained by harm reduction group

Louisiana State

Adams County, MS

Mississippi News Group

Written with artificial intelligence assistance. July 26, 2024 – According to the Darkhorse Press, a late-night raid led by the Adams County Sheriff’s Office Special Operations Group resulted in significant drug and firearm seizures, as well as multiple arrests.

Early Morning Drug Bust Leads to Multiple Arrests in Adams County

Denver, CO

More dangerous substances are entering the Denver drug supply, Harm Reduction Action Center warned in a newsletter this week. “The Iron Law of Prohibition posits that as law enforcement becomes more intense, the potency of prohibited substances increases,” HRAC Executive Director Lisa Raville wrote in the newsletter. That is exactly what is happening, she said.

Dangerous substances entering Denver drug supply

Wyoming State

WyoFile

Two Sweetwater County lawmakers seeking re-election filed a defamation suit Thursday against a political action committee affiliated with the hard-line Wyoming Freedom Caucus over mailers that attack them over a vote they say never happened.

Lawmakers sue Wyoming Freedom PAC over Trump-ballot mailers

Everyday Health

Inhalers and nebulizers are vital in treating COPD. But how do you know which one is right for you? Here's a rundown to keep you informed.

How to Make Sense of Inhaled Medications for COPD

In addition to collecting more than 8,000 used needles in the past year from Denver drug users, the Harm Reduction Action Center passed out 10,000 meth pipes and “snort kits,” according to a newsletter sent to its supporters Thursday. They also connected about 1,700 people to medical, mental health and substance abuse treatment.

Denver group hands out 10K meth pipes, ‘snort kits,’ connects 1,700 to treatment annually

NewsBreak

Treprostinil Inhalation Powder (Yutrepia) Receives Tentative Approval for PAH and PH-ILD

On August 19, 2024, Liquidia Corporation announced the FDA's tentative approval of treprostinil inhalation powder for adults with PAH and PH-ILD. The US Food and Drug...

Treprostinil Inhalation Powder (Yutrepia) Receives Tentative Approval for PAH and PH-ILD

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