XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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FDA Approval Pharmacy Drugs Regulation 98

Pharmaceutical Technology

OCTOBER 1, 2022

Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water. The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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FDA Approval Pharmacy Doctor Doctors 244

XTalks

OCTOBER 16, 2024

Stelara Price Reductions and Expanding Biosimilar Competition Imuldosa’s approval joins a wave of Stelara biosimilars. In October 2023, Amgen’s Wezlana (ustekinumab-auub) became an interchangeable biosimilar approved by the FDA, eligible for pharmacy-level substitution.

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FDA Approval Marketing Pharmacy Development 103

XTalks

JUNE 3, 2024

Yesafili and Opuviz are approved to treat the same conditions as Regeneron’s vascular endothelial growth factor (VEGF) inhibitor Eylea — neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy, macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME). According to Biocon, there are 19.8

FDA Approval 98

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Fierce Pharma

AUGUST 17, 2023

company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. retail pharmacies, the company said. . | As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K.

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Pharmacy Vaccine Vaccination FDA Approval 79

Pharmaceutical Technology

MAY 24, 2023

The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on.

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FDA Approval Pharmacy Pharma Companies Containment 147

XTalks

MAY 25, 2022

On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia. This approval is significant because prior to Quell, there were no FDA-approved medical devices for fibromyalgia treatment.

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FDA Approval Clinical Trials Clinical Trials Drugs 105

XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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FDA Approval Pharmacy Marketing Medicine 81

STAT News

AUGUST 18, 2022

Hello, everyone, and how are you today? We are doing just fine, thank you, courtesy of clear blue skies and cool breezes circling about the relatively quiet Pharmalot campus. We are busy, though, firing up the coffee kettle, since a cup or three of stimulation is in order. Our choice today is maple bourbon.

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Gene Therapy Gene FDA Approval Pharmacy 98

Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.

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Pharmacy Checkers

FEBRUARY 14, 2020

Joe and Teresa Graedon, founders of The People’s Pharmacy , not only have an admirable track record of telling health consumers how it is, but also listening to those in their readership. pharmacies, like Walgreens or CVS, costs more than $2,000 out-of-pocket for just a month’s supply. “So Wellbutrin XL 300mg sold at U.S.

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Branding FDA Approval Pharmacy Bioequivalency 62

Pharmaceutical Technology

SEPTEMBER 2, 2022

The company plans to make Konvomep available commercially in pharmacies across the country in the first quarter of next year. Azurity Pharmaceuticals CEO Richard Blackburn said: “We are very pleased that patients will soon have access to this FDA-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor.

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XTalks

JANUARY 29, 2025

This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval. Zepbound was approved in 2023 as the obesity counterpart of Eli Lillys GLP-1 blockbuster Mounjaro. Its changing how much weight I lose, up to 48 lbs, he says.

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FDA Approval Drugs Hormones Marketing 71

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

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FDA Approval Drugs Gene Therapy Protein 59

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

FDA Approval 81

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XTalks

SEPTEMBER 21, 2023

Among the companies Lilly has accused of selling non-US Food and Drug Administration (FDA) approved compounded products “fraudulently claiming to be Mounjaro” are medical spas, wellness centers and compounding pharmacies. Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes.

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Pharmacy FDA Approval Drugs Containment 59

XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

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FDA Approval Branding Drugs Pharmacy 105

Pharmaceutical Technology

OCTOBER 31, 2022

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA. “If

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

XTalks

DECEMBER 18, 2024

It also received the FDAs rare pediatric disease priority review voucher along with the approval, which will help expedite the agencys assessment of another application. The company said Crenessity will be available through specialty pharmacy PANTHERx Rare in order to centralize and simplify fulfillment of prescriptions for the drug.

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Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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XTalks

JULY 10, 2023

With the remarkable success of its semaglutide products Wegovy and Ozempic for weight loss and type 2 diabetes, respectively (the latter also for weight loss through off-label prescribing), Novo Nordisk is cracking down on pharmacies making compounded versions of the glucagon-like peptide-1 (GLP-1) receptor agonist drugs.

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Pharmacy FDA Approval Licensing Licensing 90

XTalks

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

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FDA Approval Bacteria Clinical Trials Clinical Trials 105

Pharmaceutical Technology

JUNE 9, 2023

The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease.

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FDA Approval Antibody Allergies Packaging 147

Pharmaceutical Technology

MAY 5, 2023

The FDA also warned against side effects with apetamin use similar to what is seen with antihistamine overdose, such as hallucinations, convulsions, coma and even death. In this area too, online pharmacies like Ro have begun to make a splash by offering these drugs on their platforms.

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Pharmaceutical Commerce

DECEMBER 18, 2023

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

FDA Approval 52

FDA Approval Dermatology Pharmacy 52

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient. Source link.

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XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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Life Science FDA Approval Dermatology Pharmacy 52

XTalks

SEPTEMBER 25, 2024

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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FDA Approval Vaccination Vaccine Pharmacy 52

XTalks

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

FDA Approval 98

FDA Approval Bacteria Clinical Trials Clinical Trials 98

BioTech 365

SEPTEMBER 15, 2020

US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk Package for the gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine) As the only polymer bottle for an MRI contrast agent, Clariscan in +PLUSPAK offers the potential for increased workplace safety, efficiency, convenience and … Continue reading →

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FDA Approval Packaging Packaging Pharmacy 40

Pharmacy Checkers

JULY 11, 2019

As an option for those who cannot afford that, PharmacyChecker found that 25% of the generic medications were available online, internationally through pharmacies that are accredited in the PharmacyChecker Verification Program. Read the white paper: Newly Approved Generics: Cost and Lack of Availability in the United States.

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Generic Drugs FDA Approval Drugs Branding 48

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The report also shows a rapid rise in compounding pharmacies.

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Pharmacy Drugs Production Sales 104

NPR Health - Shots

MARCH 29, 2023

The FDA approved Narcan for sale without a prescription. The opioid overdose reversal drug would be available at pharmacies and convenience stores nationally, increasing access as opioid deaths climb.

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Sales FDA Approval Pharmacy Drugs 54

XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. mg and 2.4

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FDA Approval Containment Drugs Pharmacy 98

XTalks

FEBRUARY 25, 2025

Related: FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease In the US, over 100 million adults are affected by obesity, and it is projected that nearly 49% of the population will face the condition by 2030. Moreover, the high demand for GLP-1 drugs also led to shortages of the drugs over the past couple of years.

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Drugs Packaging Packaging Pharmacy 59

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. This initial approval was only for treatment of excessive daytime sleepiness. Wake up and go to sleep.

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FDA Approval Marketing Containment Drugs 116