Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. On March 5, the U.S. Following this announcement, Dexcom’s shares experienced a 2.2% increase in extended trading.

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Food and Drug Administration FDA Food Management 52

Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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Legacy MEDSearch

OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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Food and Drug Administration FDA Side effects Recruitment 98

Legacy MEDSearch

OCTOBER 30, 2023

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. “We are pleased to bring technologies to the U.S.

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Food and Drug Administration FDA Distribution Recruitment 52

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid.

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Food and Drug Administration FDA Consulting Food 52

European Pharmaceutical Review

FEBRUARY 8, 2024

Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.

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Food and Drug Administration Medicine Medical Consulting 89

Pharmaceutical Technology

MAY 17, 2023

Last month, the therapy received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to treat hospitalised Covid-19 adult patients. The partnership represents another remarkable milestone in our efforts to establish a robust manufacturing network on a global scale. “We

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Pharmaceutical Technology

MARCH 10, 2023

It represents one of the largest-ever global private-sector investments in the country and strengthens the company’s Europe-wide production network. Recently, the company unveiled a $52.8m (€50m) additional investment for expanding its antibiotics production network in Europe.

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Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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Pharmaceutical Food and Drug Administration Pharmaceutical manufacturing Manufacturing 52

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.

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Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.

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Food and Drug Administration Pharma Medicine Distribution 52

Legacy MEDSearch

MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. FemDx Medsystems, Inc., a women’s health startup based in Santa Clara, CA announces the company has received U.S. FemDx Medsystems, Inc.,

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Food and Drug Administration FDA Recruitment Physicians 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Safety Food and Drug Administration Pharmaceutical Marketing 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. appeared first on Pharma Marketing Network.

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Legacy MEDSearch

NOVEMBER 14, 2022

Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022. Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S.

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Food and Drug Administration FDA Recruitment Food 52

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. Cedars-Sinai’s Institutional Review Board (IRB) will monitor the studies for Alpha network sites. Scientific and operational teams.

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Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Food & Drug Administration (FDA). CurvaFix, Inc., The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients.

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Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. Today millions of Americans use DOACs, a highly effective and widely used drug for managing atrial fibrillation and deep vein thrombosis. DOACs can elevate bleeding risk and complicate emergency care.

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Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Food and Drug Administration Side effects Recruitment Safety 52

Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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Legacy MEDSearch

MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., Are you hiring?

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Food and Drug Administration FDA Recruitment Medical 52

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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Pharma Marketing Network

MARCH 23, 2023

However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease. One of the most notable breakthroughs in Alzheimer’s treatment is the approval of Aduhelm, a new drug developed by Biogen, by the U.S. Food and Drug Administration (FDA) in June 2021.

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Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S.

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Food and Drug Administration FDA Recruitment Food 98

PM360

FEBRUARY 12, 2024

Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?

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Pharma Marketing Network

MAY 11, 2023

However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease. One of the most notable breakthroughs in Alzheimer’s treatment is the approval of Aduhelm, a new drug developed by Biogen, by the U.S. Food and Drug Administration (FDA) in June 2021.

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Food and Drug Administration FDA Consulting Pharma 52

Legacy MEDSearch

DECEMBER 12, 2022

IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners. For more information, please visit www.irras.com.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Globalisation and supply chain complexity are a factor.

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Pharmaceutical Food and Drug Administration Transportation Manufacturing 95

Legacy MEDSearch

OCTOBER 10, 2023

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System.

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Food and Drug Administration FDA Recruitment Marketing 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). European Network for Health Technology Assessment EMA. References.

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Legacy MEDSearch

DECEMBER 6, 2022

Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021. To date, multiple major hospital networks across the U.S. This is a proud day in Activ Surgical’s history.”.

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Food and Drug Administration Safety Recruitment Medical 98

European Pharmaceutical Review

JANUARY 19, 2023

With the skills, experience and networks they will gain… in the Winn Award Program, [the programme participants] will make a significant difference in how healthcare is delivered in the US,” stated Jude Ngang, Executive Director, and leader of the Amgen Representation in Clinical Research (RISE) programme.

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Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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FDA Food and Drug Administration Recruitment Management 95

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Food and Drug Administration Manufacturing Engineering Pharmacology 78

European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Food and Drug Administration Manufacturing Safety Transportation 79

Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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