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

Inspire Medical Systems, a medical technology company focused on the development and commercialization of minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the FDA approval of the Inspire V therapy system which includes the next generation neurostimulator and the associated Bluetooth patient remote and physician programmer. Inspire...

FDA Approves 'Mask-Free' Sleep Apnea Treatment Device

Servier has expanded its IDH drug armamentarium with the FDA approval for an IDH1/2 dual inhibitor. The approval represents the first major treatment advance in low-grade brain cancer in more than two decades. The new FDA approval is for Servier’s Voranigo, or vorasidenib, for adult and children ages 12 and...

Servier snags FDA approval for Voranigo, the first targeted therapy for a common type of brain tumor

The FDA on Monday approved Ascendis Pharma’s palopegteriparatide, which was developed as TransCon PTH, for the treatment of adults with the rare endocrine disorder hypoparathyroidism. The drug will be marketed under the brand name Yorvipath. The company is currently wrapping up the manufacturing of Yorvipath and expects the product...

Ascendis’ Hypoparathyrodism Drug Secures FDA Approval Following Tough Regulatory Path

Ascendis Pharma should be well prepared for the U.S. launch of its hormone replacement therapy for hypoparathyroidism, which was approved on Friday by the FDA. After all, the company was initially set to bring the drug to the market 15 months ago before the FDA rejected it with a surprise complete response letter (CRL). Then three months ago, Ascendis again was ready to roll before the U.S. regulator said it needed an additional three months to make its decision.

Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Interesting Engineering

Patients experienced a significant reduction in pain, improved their quality of life, and even showed signs of cartilage regrowth.

Stem cell shot reverses osteoarthritis, repairs knee cartilage, cuts pain by 58%

Healthline

The FDA has approved vonoprazan (Voquezna), a new daily treatment for heartburn associated with GERD in adults.

FDA Approves New GERD Treatment Vonoprazan for Heartburn Relief

In this interview, Kim speaks about the significance of the FDA approval of neffy for patients who face the threat of anaphylaxis and other severe allergic reactions. The US Food and Drug Administration (FDA) approved an epinephrine nasal spray formulated for emergency treatment of adults and children with severe allergic reactions like anaphylaxis. This treatment, the first non-injectable option for severe allergic reactions, is known as ‘neffy.’1.

Impact of Nasal Epinephrine Spray for Patients with Severe Allergies, with Edwin H. Kim, MD

ARS Pharmaceuticals (Nasdaq:SRPY) announced that it received FDA approval for its neffy (epinephrine nasal spray) 2 mg for treating of Type I allergic reactions. Approval includes the treatment of anaphylaxis, with the indication covering adults and children who weigh ≥30 kg (66 lbs.). It marks a major innovation in epinephrine delivery as the first and only needle-free treatment option for people with severe allergic reactions. neffy could provide an alternative to the popular EpiPen option that utilizes a needle.

ARS Pharmaceuticals wins first FDA approval for needle-free, nasal epinephrine

Savannah, GA

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Daily Coffee Press

Newly returned indictments in the Southern District of Georgia include felony charges for illegal firearms possession and drug distribution, while additional defendants have been sentenced to federal prison or await further proceedings after pleading guilty to federal gun charges.

Federal Charges in Southern GA: Indictments and Sentences for Firearms and Drug Offenses

Florida State

Jacksonville Today

Republican Donald Trump has a 7-point lead over Democrat Kamala Harris among Florida voters, 49% to 42%, according to a new poll from the University of North Florida. Four percent are backing another candidate, and 6% are undecided or didn’t answer.

New Florida poll: Trump leads; support strong for abortion and recreational weed

Sandoz announced that the FDA has approved Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu™ is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Sandoz Receives FDA Approval for Enzeevu™ Biosimilar

Tampa, FL

Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections. The FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray), a first-in-class needle-free, nasal spray treatment for type I allergic reactions, such as anaphylaxis, for adults and children weighing 66 lbs. or more. According to the company, this approval offers a less painful alternative to traditional needle injections, which are often delayed due to anxiety, potentially worsening allergic reactions.1.

FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis

Huxley Medica has received 510(k) clearance from the FDA for its chest-worn, sleep apnea diagnostic patch, SANSA. With this clearance, Huxley Medical can move forward to market its device. The patch is an at-home, single-point-of-skin-contact diagnostic device. Unlike current patches, rings, watches, or finger probes, SANSA does not require additional...

FDA Clears At-Home Sleep Apnea Test Patch

Topamax (topiramate) is a brand-name drug that’s prescribed to help prevent migraine headaches. This article covers topics such as side effects, dosage, and how Topamax works. Topamax is available in these forms: oral tablets and sprinkle capsules. Topamax belongs to a drug class called anticonvulsants. The medication is available...

Topamax for migraine

The researchers concluded that "combining canaloplasty with cataract surgery does not compromise the efficacy or safety of the former and might provide a higher absolute IOP reduction and reduced medication burden." Photo: James L. Fanelli, OD. Click image to enlarge. Most studies of canaloplasty efficacy limit their follow-up periods to...

Canaloplasty Provides Long-term IOP Reduction for Glaucoma Patients

The FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). "Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is...

FDA Approves First Nasal Spray for Treatment of Anaphylaxis

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

Announced today that it received FDA approval for asleep deep brain stimulation (DBS) surgery for people with Parkinson’s and essential tremor (ET). The medtech giant says it’s the first and only company to win FDA approval to offer DBS surgery while a patient is asleep (under general anesthesia) or awake.

Medtronic wins FDA nod for asleep deep brain stimulation surgery

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

NewsBreak

FDA Approves Palopegteriparatide for Hypoparathyroidism

Palopegteriparatide’s approval was based on positive data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials. The US Food and Drug Administration (FDA)...

FDA Approves Palopegteriparatide for Hypoparathyroidism

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