2024, Food and Drug Administration and Sales

2024

Food and Drug Administration

Sales

Promising schizophrenia drug faces tough competition

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 ). GlobalData’s report showed LY03010 is expected to launch in the US in 2024. If successful, the drug is forecasted to reach sales of $63.5

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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). We do not expect entry of Stelara biosimilars in the United States during 2024,” Joseph Wolk CFO, Johnson & Johnson, stated during the company’s Q3 earnings call on 18 October.

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FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis

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. ” The final results from AGENT IDE are expected to be presented at CRT 2024.

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FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

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. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. On March 5, the U.S.

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Alimera Sciences buys US rights to EyePoint’s Yutiq

Pharmaceutical Technology

MAY 19, 2023

It received approval from the US Food and Drug Administration in October 2018. will be paid in equal quarterly instalments in 2024. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.

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Celltrion’s Yuflyma receives US FDA approval for multiple conditions

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.

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Blue Water Vaccines agrees to buy Veru’s Entadfi capsules business

Pharmaceutical Technology

APRIL 21, 2023

It will pay another $10m in instalments through to September 2024. The remaining $80m component of the deal is based on the achievement of annual sales milestones. The US Food and Drug Administration granted approval to Entadfi for the treatment of BPH in December 2021.

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FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System

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.

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Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

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. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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Scorpion inks deal with Pierre Fabre for next-gen EGFR inhibitors

Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. billion in 2029. GlobalData is the parent company of Pharmaceutical Technology.

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UniQure sells part of Hemgenix royalty rights in deal worth up to $400 million

Pharmaceutical Technology

MAY 16, 2023

This comes with an upfront cash payment of $375 million, with a potential additional $25 million if Hemgenix net sales reach a certain milestone in 2024, based on a May 15 announcement. Additionally, UniQure was set to get tiered royalties of up to “a low-twenties percentage” of net product sales related to Hemgenix. million.

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Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene

Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Global expansion will begin in 2024. The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S.

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Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024.

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BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg™; Its New Motor-Robotic Prosthetic Knee

Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies.

FDA

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Surmodics Receives FDA 510(k) Clearance for Pounce™ LP Thrombectomy System

Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy 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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The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. ReGelTec, Inc. announced that the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Teva says medicines access at risk in Northern Ireland

pharmaphorum

NOVEMBER 16, 2022

“They say need for two product licences under the Centralised Procedure ‘creates an administrative and cost burden that will make many medicines unviable to supply to NI’ This level of disruption is unacceptable and unjustifiable.” “The warning presented by Teva UK is stark,” according to Cameron.

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Pharma Rep Focus

Promising schizophrenia drug faces tough competition

FDA approves first Stelara biosimilar, Wezlana

Trending Sources

FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis

FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

Alimera Sciences buys US rights to EyePoint’s Yutiq

Celltrion’s Yuflyma receives US FDA approval for multiple conditions

Blue Water Vaccines agrees to buy Veru’s Entadfi capsules business

FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System

Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Scorpion inks deal with Pierre Fabre for next-gen EGFR inhibitors

UniQure sells part of Hemgenix royalty rights in deal worth up to $400 million

Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg™; Its New Motor-Robotic Prosthetic Knee

Surmodics Receives FDA 510(k) Clearance for Pounce™ LP Thrombectomy System

The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease

Teva says medicines access at risk in Northern Ireland

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