FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, M.D., M.H.S., direct...

May 15, 2023 | Monday | News
Singlera Genomics' PDACatch Gets FDA Breakthrough Designation for Pancreatic Cancer Liquid Biopsy

Pancreatic adenocarcinoma (PDAC) is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage; the five-year surviv...

May 09, 2023 | Tuesday | News
MIVI Q™ Revascularization System Clinical Trial for Stroke Treatment Completes Enrollment

The EVAQ Trial enrolled 121 patients at 17 centers globally. Data from the study will be used as part of an application to the U.S. Food and Drug Administr...

May 04, 2023 | Thursday | News
Nanox.ARC Imaging System Receives FDA Clearance, Pioneering a New Era in Medical Imaging

NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received a ...

May 02, 2023 | Tuesday | Regulatory
Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials With Its Botulinum Toxin

Aquavit will begin its Phase II/Phase III trials for DTX-023 (aqubotulinumtoxinA) and DTX-024 (aqubotulinumtoxinA with intradermal microinjector) under the...

May 01, 2023 | Monday | News
Roche's Columvi Gets CHMP Nod for Fixed-Duration Use in Diffuse Large B-cell Lymphoma

The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete r...

April 27, 2023 | Thursday | Regulatory
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA

The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partnership with Promimic AB. NanoVy-HA is a process in which...

April 26, 2023 | Wednesday | Regulatory
Tofersen's FDA accelerated approval highlights blood neurofilament light chain's significance as surrogate endpoint in neurology trials

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today...

April 26, 2023 | Wednesday | News
Avidity Biosciences' AOC 1044 gets FDA Fast Track for Duchenne Muscular Dystrophy treatment

Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotid...

April 25, 2023 | Tuesday | News
Virios Therapeutics gets FDA feedback on IMC-1 Phase 3 program for Fibromyalgia treatment

-Virios’ IMC-1 Phase 3 Proposed Program is Considered Acceptable based on Initial FDA Feedback Pending Review of the Final Chronic Toxicology Program...

April 25, 2023 | Tuesday | News
FDA Approves Medtronic MiniMed™ 780G System - World's First Insulin Pump with Meal Detection Technology and 5-Minute Auto Corrections.

 Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its Mini...

April 22, 2023 | Saturday | News
FDA approves Roche's Polivy for untreated diffuse large B-cell lymphoma

Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive dise...

April 20, 2023 | Thursday | News
Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...

April 20, 2023 | Thursday | News
FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

What You Need to Know: Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of ...

April 19, 2023 | Wednesday | Regulatory

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