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).

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Food and Drug Administration FDA Prescription Medicine 97

PM360

APRIL 4, 2025

Importantly, across all 11 patients between the ages of 1 and 11 who were dosed with RGX-202, there have been no serious adverse events or adverse events of special interest, such as drug-induced liver injury, which was the cause death for the 16-year-old boy after being treated with Elevidys.

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Pharma Marketing Network

MARCH 11, 2025

Strict guidelines from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) require marketers to ensure transparency and accuracy in all communications. Resources like the FDAs OPDP (Office of Prescription Drug Promotion) provide guidance on drug advertising and communication.

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Marketing Pharma Food and Drug Administration Education 52

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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Medicine Food and Drug Administration Transportation Distribution 116

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Thus, LAMP assays, combined with DNA extraction by boiling, can be used as effective methods to detect BCC strains found in drug ingredients, pharmaceutical-grade water, and finished pharmaceutical products.”.

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Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

Pharmaceutical Technology

SEPTEMBER 29, 2022

A flagship company of the Torrent Group, Torrent Pharmaceuticals is a speciality-focused firm with more than 74% of its revenue from chronic and sub-chronic therapies in India. Among these facilities, four are approved by the US Food and Drug Administration (FDA).

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Food and Drug Administration Pharma Specialization Food 59

Legacy MEDSearch

JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Co-founded by Dr. Jihad Mustapha and Dr. Fadi Saab, ACV Centers has a special concentration on treating peripheral artery disease and the complications of critical limb ischemia. Cardio Flow, Inc.,

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Food and Drug Administration FDA Recruitment Medical 98

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. It is specialised in innovative processes for producing difficult-to-manufacture speciality and generic drugs.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Pharmaceutical Technology

MAY 12, 2023

Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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Food and Drug Administration Pharmaceutical FDA Specialization 52

Legacy MEDSearch

DECEMBER 7, 2022

Food and Drug Administration market clearance for the ArthroFree System. This was followed by additional partnerships with Hospital for Special Surgery (HSS) in New York, University Hospitals of Cleveland, and LG Electronics USA.”. “We The company hit an important milestone in March 2022 when it received U.S.

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Networking Medical Food and Drug Administration Recruitment 98

Pharmaceutical Technology

OCTOBER 3, 2022

The board of directors of Myovant constituted a special committee of independent directors including its audit committee members to assess the proposal. The special committee decided that the deal substantially undervalues Myovant and is not in the firm’s or its minority shareholders’ best interests.

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Pharmaceutical Technology

MAY 17, 2023

“To ensure wide access to eligible patients, we are excited to partner with the IDEOGEN Group, a company focused on the commercialisation of speciality medicines for rare diseases across Europe.” In 2010, the US Food and Drug Administration approved Glassia for the same indication.

Marketing 52

Marketing Food and Drug Administration Specialization Food 52

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York.

Marketing 96

Marketing FDA Food and Drug Administration Recruitment 96

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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Pharmaceutical Technology

SEPTEMBER 2, 2022

The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. A pharmaceutical firm, Azurity focuses on developing new products for the special requirements of overlooked patients.

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Food and Drug Administration FDA Specialization Pharmaceutical 52

Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc.,

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Food and Drug Administration Physicians Recruitment Medical 97

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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Food and Drug Administration Patients Medical Networking 105

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. So, here they are: 1.

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Medical Food and Drug Administration Healthcare Healthcare 98

Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Marketing Food and Drug Administration Pharma Doctors 52

European Pharmaceutical Review

NOVEMBER 15, 2022

Lorrie is leader of the GAMP laboratory Special Interest Group and Co-Chair of the GAMP Data Integrity Special Interest Group. Charlie Wakeham currently serves as Secretary of ISPE GAMP Global Council and on the GAMP Global CSA SIG Leadership Team.

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Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

European Pharmaceutical Review

FEBRUARY 24, 2023

The risks linked to contamination have led regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to implement strict requirements on process characterisation and validation. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

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Food and Drug Administration Engineering Specialization Food 98

Clarify Health

NOVEMBER 21, 2022

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Clarify Health decided to investigate the tactics deployed by banks and online retailers like Amazon. But the U.S.

Food and Drug Administration 52

Food and Drug Administration Transportation Food Recruitment 52

Penrod

JUNE 6, 2024

Life Sciences Cloud also drives compliance with various regulatory agencies, such as the US Food and Drug Administration. By providing specialized features for both commercial and clinical operations, Salesforce is addressing the unique challenges faced by these industries.

CRM 52

CRM Food and Drug Administration Healthcare Provider Management 52

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. How can a newly expanded definition of precision medicine help?

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing FDA 52

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc. Dr. Itatani, MD, Ph.D.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

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Medical sales Medical Sales Patients 130

Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. ” Pediatric medical innovation remains a challenge.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

MARCH 16, 2023

Nurses or technicians can easily perform a bedside measurement and obtain a clear negative or positive output in less than 5 minutes without requiring specialized personnel or complicated equipment. 2 In the US, $164 billion is spent annually on acute brain failure 1 , rivaling costs associated with heart disease and diabetes.

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FDA Patients Food and Drug Administration Recruitment 52

LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. Class II: requires general controls and special controls with and without exemptions and poses a moderate risk. You need to be a trusted partner for both patients and their providers alike. . Bringing Your Medical Device to the Market.

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Medical Marketing Patients Food and Drug Administration 52

Pharmaceutical Technology

AUGUST 24, 2022

The importance of ribbon density has previously been emphasized by Helen Winkle [1] from the US Food and Drug Administration (FDA) and it becomes clear then that maintaining the ribbon density by setting the correct force and gap is crucial for the final granulates. References. [1] 2] Gamble, J. et al, Pharmaceut.

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Food and Drug Administration Manufacturing Pharmaceutical Specialization 52

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. So, here they are: 1.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

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Food and Drug Administration Education Insurance Healthcare 52

Clarify Health

NOVEMBER 21, 2022

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Clarify Health decided to investigate the tactics deployed by banks and online retailers like Amazon. But the U.S.

Food and Drug Administration 40

Food and Drug Administration Transportation Food Recruitment 40