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. physicians the opportunity to treat their patients with this novel device.” Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s

Food and Drug Administration 239

Food and Drug Administration Physicians Side effects Doctors 239

European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 GlobalData’s report showed LY03010 is expected to launch in the US in 2024. million in 2031, representing 0.6

Competition 95

Competition Food and Drug Administration Pharma Food 95

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.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

Food and Drug Administration 85

Food and Drug Administration FDA Food Medicine 85

Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

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. For more information, see www.medinol.com.

Food and Drug Administration 52

Food and Drug Administration FDA Distribution Recruitment 52

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

JUNE 20, 2023

The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity. In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Medicine 98

Pharmaceutical Technology

APRIL 3, 2023

BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. 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

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 company is focusing on Fragility Fractures of the Pelvis and high-impact pelvic fractures.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Clinical response was observed after just two weeks in some cases.

Food and Drug Administration 105

Food and Drug Administration FDA Sales Food 105

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. Receives FDA Clearance For Its FalloView™ Falloposcope appeared first on Legacy MedSearch | Medical Device Recruiters.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. ” The Breakthrough Devices Program will offer ABS the opportunity for more interactive and efficient communication with the FDA during the premarket review phase. . Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Food 52

Legacy MEDSearch

NOVEMBER 14, 2022

Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022. See Full Press Release at the Source: Xironetic Receives FDA Clearance for Augmented Reality Surgical Software. Xironetic is headquartered in Oklahoma City. Press Release by: Xironetic.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Food 52

World of DTC Marketing

JANUARY 10, 2022

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9

Food and Drug Administration 213

Food and Drug Administration Pharma Marketing Food 213

Legacy MEDSearch

FEBRUARY 13, 2023

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. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

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. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

FDA 98

FDA Food and Drug Administration Recruitment Medicine 98

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. This is a truly disruptive technology in a crowded area. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. For more information, please visit www.irras.com. Are you hiring?

FDA 95

FDA Food and Drug Administration Recruitment Networking 95

Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. See Full Press Release at the Source: ABM RESPIRATORY CARE ANNOUNCES THE FDA CLEARANCE OF THE BIWAZE CLEAR SYSTEM. For more information visit, www.abmrc.com. . Press Release by: ABM Respiratory Care. Are you hiring?

FDA 95

FDA Food and Drug Administration Recruitment Management 95

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Food FDA 52

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards.

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

Pharmaceutical Technology

JUNE 6, 2023

NRx Pharmaceuticals will receive an initial payment of $10m on obtaining successful findings from the ongoing Phase IIb/III clinical trial and on completion of a Type B meeting with the US Food and Drug Administration (FDA).

Food and Drug Administration 52

Food and Drug Administration Sales FDA Food 52

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. Are you hiring?

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The post Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System appeared first on Legacy MedSearch | Medical Device Recruiters. Axonics, Inc., Are you hiring?

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Dagi Ben-Noon , CEO of Inspira, stated that, “We are preparing for global deployments of our INSPIRA ART100 systems once FDA clearance is achieved. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

APRIL 12, 2023

Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients.

Food and Drug Administration 59

Food and Drug Administration Patients FDA Food 59

Pharmaceutical Technology

NOVEMBER 11, 2022

For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In October, the US Food and Drug Administration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.

Food and Drug Administration 96

Food and Drug Administration Food FDA Sales 96

European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 billion in Q3 from its eye disease drug Eylea. percent from $3.45 trillion in Q2 2022 to $3.14

Biopharma 72

Biopharma Marketing Food and Drug Administration Sales 72

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?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.” “I

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.

Food and Drug Administration 59

Food and Drug Administration Medical FDA Marketing 59

Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is claimed to be the only oral antifungal to receive approval from the US Food and Drug Administration (FDA) to treat VVC, as well as reducing RVVC incidence. It will also receive an additional $15m in milestone payments, upon receipt of US FDA approval for an additional indication.

Food and Drug Administration 52

Food and Drug Administration FDA Food Sales 52

European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. Worldwide sales for Humira peaked at $21.2 This has developed following numerous adalimumab biosimilar offerings being brought to market. billion in 2022, a product that was launched in 2002.

Marketing 76

Marketing Food and Drug Administration Food Medicine 76

Legacy MEDSearch

OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES System with select hospitals and health systems. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52