Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolor has already obtained FDA approval for pre-operative administration.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

Nixon Gwilt Law

MAY 29, 2024

Despite the potential of SaMD/DTx tools, navigating the FDA’s regulatory requirements can be daunting, especially for pre-revenue digital health developers with limited resources. Compliance can be time-consuming and resource-intensive, requiring specialized skills for clinical studies and evidence generation for validation.

Marketing 96

Marketing FDA Medical Management 96

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. Moximed is based in Fremont, California. Are you hiring?

Marketing 96

Marketing FDA Food and Drug Administration Recruitment 96

Pharma Marketing Network

MARCH 20, 2025

To enhance digital ad performance, pharma marketers can utilize platforms like eHealthcare Solutions , which specializes in pharma advertising solutions tailored for reaching HCPs and patients. Marketers must ensure that their campaigns adhere to FDA, HIPAA, and GDPR guidelines to avoid legal complications.

Pharma 52

Pharma Networking Marketing Media 52

Pharmaceutical Technology

JULY 1, 2024

The US FDA has approved speciality pharmaceutical company Shorla Oncology’s NDA for TEPYLUTE to treat breast and ovarian cancer.

FDA 52

FDA Specialization Pharmaceutical 52

Pharma Marketing Network

MARCH 18, 2025

Best For: Targeting verified HCPs in a compliant and specialized environment. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations. Following FDA regulations, using fair balance messaging, and targeting verified HCPs helps maintain compliance.

Pharma 52

Pharma Marketing Networking Healthcare 52

Pharma Marketing Network

FEBRUARY 17, 2025

With their specialized expertise, they understand the complex regulatory environment and can craft campaigns that resonate with your target audience while staying compliant. Industry Experience and Proven Track Record Does the company specialize in pharmaceutical marketing, or is healthcare just one of many industries they serve?

Marketing 52

Marketing Pharmaceutical Pharma Prescription 52

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

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., Are you hiring?

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

Pharma Marketing Network

MARCH 19, 2025

For advanced social media advertising solutions, platforms like eHealthCare Solutions offer specialized tools for reaching HCPs and targeted pharma audiences. Social media analytics should always align with FDA, HIPAA, and GDPR regulations to protect patient privacy and ensure ethical marketing practices.

Media 52

Media Marketing Pharma Ethics 52

Legacy MEDSearch

FEBRUARY 8, 2023

market with a breakthrough FDA-Class II medical device, TargetCool. ” TargetCool was created by award-winning South Korean mechanical engineer, Dr. Gun-Ho Kim, who specializes in thermal engineering. Recens, Inc. “We truly believe that TargetCool will change the face of cooling,” Dr. Kim stated. Are you hiring?

Management 98

Management Medical Marketing FDA 98

Pharmaceutical Technology

APRIL 3, 2023

As part of the new deals, BioNTech will have commercial rights to the ADCs worldwide, excluding mainland China, the Hong Kong special administrative region and the Macau special administrative region. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe.

Food and Drug Administration 98

Food and Drug Administration Specialization Food Manufacturing 98

Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. LUMRYZ represents a new generation of oxybate treatment that the FDA deems clinically superior to twice-nightly oxybate treatments. LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Specialization Food 98

Pharmacy Times

NOVEMBER 16, 2022

Experts in the management of SARS-CoV-2 educate on CDC and FDA recommendations for approaching administration of booster vaccines, including those for special patient populations.

FDA 49

FDA Specialization Education Management 49

World of DTC Marketing

MARCH 11, 2022

After two years of pandemic fatigue, healthcare trust is at an all-time low, according to Edelman’s Trust Barometer Special Report on Trust in Healthcare. Wegovy, for example, has been approved by the FDA to treat obesity and excess weight – conditions that can lead to type 2 diabetes and prediabetes.

Physicians 212

Physicians Healthcare Healthcare Pharma 212

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. FDA Guidelines and Promotional Review Committees Understanding FDA regulations is critical for all pharma marketing professionals.

Marketing 52

Marketing Pharma Food and Drug Administration Education 52

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.

Food and Drug Administration 52

Food and Drug Administration FDA Specialization Pharmaceutical 52

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. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

Competition 116

Competition FDA Pharmaceutical Marketing 116

Pharma Marketing Network

NOVEMBER 15, 2024

Example: If promoting Jardiance for diabetes management, focus on unique selling points like proven efficacy and FDA approval. Ensure your ads comply with FDA guidelines. Tools to Use: Google Analytics, HubSpot, or even specialized healthcare marketing platforms. Adding a sense of urgency (“Learn more today!”)

Marketing 52

Marketing Pharma Side effects Medical 52

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.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Nixon Gwilt Law

MAY 29, 2024

Despite the potential of SaMD/DTx tools, navigating the FDA’s regulatory requirements can be daunting, especially for pre-revenue digital health developers with limited resources. Compliance can be time-consuming and resource-intensive, requiring specialized skills for clinical studies and evidence generation for validation.

Marketing 52

Marketing FDA Medical Management 52

Legacy MEDSearch

SEPTEMBER 7, 2023

FDA clearance for distribution in the United States. Specializing in digital therapeutics for respiratory care, the company is committed to delivering affordable and interoperable lung health solutions. FDA-cleared, portable digital spirometer, alveoair® is part of alveofit’s ecosystem. and emerging economies.

FDA 52

FDA Recruitment Management Healthcare 52

Infuse Medical

DECEMBER 17, 2024

Businesses like Infuse Med know the need of following laws such FDA, HIPAA, and GDPR so that their apps not only operate well but also satisfy the necessary legal criteria for medical device safety and data protection. Medical device apps can be used for a wide array of healthcare functions, such as: Tracking patient metrics (e.g.,

Medical 130

Medical Healthcare Healthcare Doctors 130

Medical Device Success

JANUARY 29, 2014

In the medical device world, the FDA and other regulatory bodies limit how we can promote many of our products. Marketo – A company that specializes in marketing automation software. Medmarc – An insurance company that specializes in insuring life science companies. For example, today I watched a webinar on video marketing.

Education 100

Education Marketing Medical Insurance 100

Legacy MEDSearch

JULY 11, 2023

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis ® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. Invictus Medical is a privately held company. Are you hiring?

FDA 52

FDA Medical Recruitment Specialization 52

Legacy MEDSearch

JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

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. The vast majority of medical devices used in pediatrics are not FDA-cleared or designed for children.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Are you hiring?

Medical 52

Medical FDA Recruitment Specialization 52

Medgadget

SEPTEMBER 29, 2023

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. CraniUS , a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system.

Medicine 105

Medicine Distribution Specialization Medical 105

Legacy MEDSearch

SEPTEMBER 1, 2022

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.

FDA 52

FDA Recruitment Marketing Medical 52

PM360

JANUARY 7, 2025

The agency provides best-in-class marketing and advertising, media strategy and purchasing, medical affairs and medical communications, value and market access services, as well as enterprise omnichannel enablement among its specialized offerings. Peregrine Market Access has been nationally recognized on the Inc.

Marketing 52

Marketing Leads Medical Consulting 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.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical FDA Specialization 52

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

Distribution 52

Distribution FDA Sales Specialization 52

PM360

AUGUST 9, 2022

While it’s unsurprising that patients flock to these cheaper alternatives to treat common conditions, generic medications aren’t as accessible for specialized conditions, which gives pharma marketers an opportunity to drive scripts where the market is less crowded. References: 1.

Prescription 52

Prescription Doctors Specialization Physicians 52

Nixon Gwilt Law

FEBRUARY 27, 2023

Notably, this rulemaking does not propose to implement the “special registration” for telemedicine providers the DEA has been promising since the Ryan Haight Act passed in 2009. Instead, it would create a new regulatory category of the “practice of telemedicine.” The proposed recordkeeping obligations listed in proposed 21 CFR §1304.03(c)(i)-(k)

Prescription 105

Prescription Medical Patients Specialization 105

European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 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.

Food and Drug Administration 52

Food and Drug Administration Specialization Biopharma Food 52