Food and Drug Administration, Patients, Prospecting and Sales

Food and Drug Administration

Patients

Prospecting

Sales

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

FDA

FDA Food and Drug Administration Recruitment Prospecting

Blueprint Medicines announces financing partnerships for $1.25bn

Pharmaceutical Technology

JULY 1, 2022

The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

Medicine

Medicine Food and Drug Administration FDA Prospecting

Join 8,000+

Insiders

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

Fierce Pharma

FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter

Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections.

FDA

FDA Food and Drug Administration Recruitment Medical

BioVentrix® Closes $48.5 Million Series A Financing

Legacy MEDSearch

APRIL 13, 2023

a privately held medical device company developing minimally invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process in patients with congestive heart failure, today announced the completion of $48.5 BioVentrix, Inc., million Series A round financing.

Food and Drug Administration

Food and Drug Administration Recruitment Medical Management

Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The study, which enrolled 299 patients across 27 U.S. Empirical Spine, Inc.,

FDA

FDA Food and Drug Administration Recruitment Patients

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. percentage of patients with conclusive reports) without the need for dilation.

FDA

FDA Food and Drug Administration Recruitment Marketing

First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process. “As a clinician, the prospect of accessing a more complete set of data intraoperatively is very exciting.”

FDA

FDA Food and Drug Administration Recruitment Medical

Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration

Food and Drug Administration Recruitment Safety Medical

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma

Pharma Food and Drug Administration Manufacturing Medicine

Pathbreakers: The journey of first generics

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

Food and Drug Administration

Food and Drug Administration FDA Medicine Competition

Intercept receives orphan drug designation for liver disease combo therapy

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

Food and Drug Administration

Food and Drug Administration FDA Pharmaceutical Prospecting

FDA grants access to new class of paediatric diabetes medicine

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration approved Boehringer Ingelheim and Eli Lilly’s oral medicines Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to manage blood sugar in children with type 2 diabetes (T2D) aged ten years or older. Eli Lilly reported it made $612.3m in the placebo group.

Medicine

Medicine FDA Food and Drug Administration Sales

Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

Food and Drug Administration

Food and Drug Administration Prescription FDA Medical

FDA AdCom votes unanimously in favour of OTC oral contraceptive

Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

FDA

FDA Food and Drug Administration Prescription Pharma

Pharma Rep Focus

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Blueprint Medicines announces financing partnerships for $1.25bn

Trending Sources

FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter

BioVentrix® Closes $48.5 Million Series A Financing

Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance

Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pathbreakers: The journey of first generics

Intercept receives orphan drug designation for liver disease combo therapy

FDA grants access to new class of paediatric diabetes medicine

Illegal online pharmacies gain traction as regulators lag behind

FDA AdCom votes unanimously in favour of OTC oral contraceptive

Stay Connected