Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. To this day, CardioSTAT has been prescribed to more than 170,000 patients.

Food and Drug Administration 98

Food and Drug Administration Food FDA Recruitment 98

Legacy MEDSearch

OCTOBER 4, 2023

Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation.

Medical 52

Medical Patients FDA Recruitment 52

World of DTC Marketing

MARCH 11, 2022

Trust, for example, in physicians is still relatively high. Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). Physician trust in the U.S. Physician trust in the U.S. Even patients will still line up if a prescription drug shows promise.

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Physicians Healthcare Healthcare Prescription 212

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Basis of the approval of the CAR-T therapy FDA’s approval of the personalised treatment is based on positive results from the Phase III CARTITUDE-4 study.

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Food and Drug Administration FDA Medicine Physicians 97

Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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Food and Drug Administration FDA Prescription Specialization 97

Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The drug-device combination product Xhance nasal spray combines a nasal anti-inflammatory drug with an exhalation delivery system (EDS).

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Prescription 52

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.” of balloon angioplasty patients and 17.9% of AGENT DCB patients. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Food and Drug Administration FDA Physicians Food 52

World of DTC Marketing

AUGUST 25, 2022

Still, consistent research has shown that they don’t provide the information patients want in a language that talks to them. Pharma companies have access to some of the best physicians in the country, and they are underutilized when helping patients understand health issues. So what’s the ROI?

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Doctors Media Physicians Pharma 227

Legacy MEDSearch

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Legacy MEDSearch

JULY 25, 2023

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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FDA Food and Drug Administration Medicine Prospecting 52

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 71

Legacy MEDSearch

MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent.

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FDA Food and Drug Administration Physicians Recruitment 52

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. They research the drug online and ask their physician about it if they decide it’s a treatment option. Again this is not true.

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Marketing Prescription Side effects Doctors 285

Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. It also provides faster run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centers, and office-based labs.

Food and Drug Administration 52

Food and Drug Administration Food FDA Physicians 52

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

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FDA Doctors Patients Prescription 81

Legacy MEDSearch

NOVEMBER 9, 2022

announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We Saranas, Inc.

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Patients Food and Drug Administration Physicians Recruitment 98

Pharmaceutical Technology

NOVEMBER 10, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. The post FDA grants EUA for Sobi’s Covid-19 treatment appeared first on Pharmaceutical Technology.

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Food and Drug Administration FDA Physicians Food 64

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc., About Tasso.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

World of DTC Marketing

DECEMBER 29, 2021

The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. There are also several physicians chiming in with their concerns over the long-term use of the drug. Wegovy can indeed help patients lose weight, but it requires that users adhere to a diet and exercise.

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Side effects Physicians Patients FDA 191

Legacy MEDSearch

MARCH 22, 2023

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. The patient population has been expanded from “patients with liver disease” to “patients with confirmed or suspected liver disease.”

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Management FDA Food and Drug Administration Physicians 52

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

Food and Drug Administration 52

Food and Drug Administration FDA Transportation Prescription 52

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. Thus, FDA funding could be what is needed on this front, says Cudkowicz.

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FDA Food and Drug Administration Physicians Side effects 98

Nixon Gwilt Law

JULY 15, 2022

In the Spring of 2022, the Centers for Medicare and Medicaid Services (“CMS”) released its 2022 Behavioral Health Strategy (the “BH Strategy”) to increase access to care and improve patient outcomes. Patient consent for GBHI1 is independently required when it is provided concurrently with other care management services.

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Physicians Management Patients Electronics 52

PM360

SEPTEMBER 7, 2023

The “Kama Sutra” for Parkinson’s patients. A card game designed to help hemophilia patients exercise. A virtual product launch for patients akin to an iPhone debut. All of these are examples of how companies are taking a little more unconventional approach to patient engagement. Marketing and Patient Engagement, argenx.

Patients 105

Patients Pharma Education Doctors 105

Pharma Leaders

MARCH 27, 2023

Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA). Iovance has submitted BLA based on positive clinical data from the C-144-01 clinical study in patients with advanced post-anti-PD1 melanoma.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

World of DTC Marketing

JUNE 2, 2021

Here are some basics: 1ne: Physicians receive a lot of emails and don’t have time to read every one. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.” Only send an email when you have something to say that will interest physicians.

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Physicians Doctors Marketing Sales 180

Legacy MEDSearch

DECEMBER 19, 2022

Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. Both the EU and FDA clinical trials will be initiated in Q2 2023 for the purpose of obtaining European and US regulatory approvals respectively in Q1 2024.

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Patients Recruitment Physicians Management 98

Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. The post US FDA approves Regeneron’s Eylea for retinopathy of prematurity in infants appeared first on Pharmaceutical Technology.

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Food and Drug Administration FDA Physicians Food 52

Legacy MEDSearch

AUGUST 22, 2022

By facilitating a more comprehensive assessment of a patient’s health and an extensive remote diagnosis, MedWand provides the crucial missing link in the delivery of telemedicine. Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As

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FDA Food and Drug Administration Physicians Medical 52