XTalks

MARCH 27, 2023

Cidara Therapeutics and Melinta Therapeutics recently announced that Rezzayo (rezafungin for injection) has been approved by the US Food and Drug Administration (FDA). Echinocandins offer a number of advantages to other antifungal medications including fewer drug-drug interactions, unique mechanism of action and fewer AEs.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

XTalks

JUNE 30, 2023

Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM).

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

The Pharma Data

OCTOBER 1, 2021

Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. there have been three patients (1.9%) with drug-related TEAEs – one on gadobutrol (paresthesia) and two on gadoterate (pruritus, urticaria). About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis.

Radiology 52

Radiology Life Science Development Production 52

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

Antibody 102

Antibody Immune Response Radiology Marketing 102

Delveinsight

SEPTEMBER 2, 2021

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.

Marketing 72

Marketing Radiology Drugs Drug Delivery 72

XTalks

MAY 13, 2022

In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. USP <1207.1>:

Packaging 98

Packaging Packaging Containment Production 98

XTalks

MAY 21, 2024

Clinical Trials Day is an opportunity to acknowledge the contributions of clinical researchers and participants and the advancements in medical science that improve patient outcomes worldwide. The FDA’s message emphasized the crucial advancements in science and technology that are propelling medicine forward.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Clinical Research 64

XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Bahassi emphasized that each one of those methods has its own challenges that limit its clinical implementation. percent show less reliability).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

SEPTEMBER 14, 2021

In the European hospital setting, the first to digitise were the picture archiving systems (PACS) in radiology departments then electronic medical records (EMRs), patient administration systems and departmental IT flow work solutions (eg, laboratory information systems and radiology information systems). About the author.

Radiology 117

Radiology Clinical Trials Clinical Trials Pharmacy 117

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

Development 99

Development Regulation Cosmetics Life Science 99

XTalks

JANUARY 19, 2024

Over the last year, there have been new acquisitions, launches and deals for novel radiotherapeutics and newly created peptide-radioisotope drug conjugates. Advantages of Alpha Emitter Therapy Over the past two decades, the radiological and chemical properties of alpha emitting isotopes have regained prominence in medical physics.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

JULY 13, 2022

The Minuteful Kidney test is Healthy.io’s most recent innovation that has acquired 510(k) clearance from the US Food and Drug Administration (FDA). It has become the first-ever digital home kidney test to enable early warning of kidney disease. “Healthy.io in the company’s press release.

Reagent 98

Reagent In-Vitro Radiology Life Science 98

The Pharma Data

NOVEMBER 19, 2020

Hojvat served as the director of the Division of Microbiology Devices at the Center for Devices and Radiological Health at the Food and Drug Administration for 12 years. Additionally, the company appointed Sally Hojvat, as a regulatory strategy advisor. Source link.

Life Science 52

Life Science Research Development Radiology 52

XTalks

MARCH 10, 2021

Along with COVID-19 vaccine authorizations, the US Food and Drug Administration (FDA) remains committed to increasing access to COVID-19 tests and supporting their development, having authorized three new tests recently for emergency use. The products encompass molecular, antigen and T cell-based testing approaches.

Protein 98

Protein RNA Antibody Production 98

pharmaphorum

MARCH 16, 2021

By using AI we can extract all the information – including symptoms, signs and drug prescription outcomes throughout the patient journey.”. There are a good number of use cases as to why pretty much every big life science company is choosing us these days,” says Medrano. AI use in the pandemic.

Doctors 112

Doctors Doctor Life Science Clinical Research 112

XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. Numerous partnerships with hospitals and other medtech companies were also announced.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

SEPTEMBER 14, 2020

Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. percent in 2021.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92