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 Recruitment Side effects 98

Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The company’s commercial strategy for the therapy includes an extensive patient support programme named RYZUP, which supports and educates those for whom the drug is prescribed and assists with access to the medicine.

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Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

MAY 22, 2024

WHO confirmed that the newly approved WLAs include: The European Medicines Regulatory Network (EMRN), which is made up of the European Commission (EC), the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 countries.

Medicine 93

Medicine Leads Food and Drug Administration Safety 93

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 The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations.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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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.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

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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Food and Drug Administration Medicine Training Electronics 98

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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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Safety Food and Drug Administration FDA Side effects 59

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

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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Food and Drug Administration Medicine Safety Food 96

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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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

JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. 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. About Visby Medical.

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Medical Food and Drug Administration FDA Recruitment 98

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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FDA Food and Drug Administration Recruitment Medical 95

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

Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Food and Drug Administration Recruitment Medical Food 98

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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FDA Food and Drug Administration Recruitment Medicine 98

European Pharmaceutical Review

FEBRUARY 15, 2023

Neoadjuvant nivolumab in combination with chemotherapy was approved by the US Food and Drug Administration (FDA) in March 2022 for lung cancer. It was successfully managed, the authors noted.

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Food and Drug Administration Patients Food Networking 98

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. 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.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

JANUARY 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Conventus Flower Orthopedics, an innovation-driven medical technology company, announced they have received U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Food and Drug Administration FDA Recruitment Marketing 97

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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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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European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

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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

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

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

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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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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 97

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 97

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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Legacy MEDSearch

JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. 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

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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Food and Drug Administration Recruitment Medical Distribution 98

Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S.

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FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

DECEMBER 8, 2022

Food and Drug Administration (FDA). 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. ChroniSense Medical Ltd.

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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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