FDA grants traditional approval for LEQEMBI® for Alzheimer's treatment

The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Nai...

July 07, 2023 | Friday | News
ResMed Acquires Somnoware, a Leader in Digital Sleep and Respiratory Care Diagnostics Software

Expands ResMed’s sleep management software solution, will help sleep labs and physicians more efficiently guide patients into and through diagnosis...

July 06, 2023 | Thursday | News
InnoCare Initiates Psoriasis Clinical Trial of ICP-488 in China

In phase I clinical trial, the single ascending doses (SAD) and multiple ascending doses (MAD) have been completed with ICP-488, demonstrating well-tolerat...

July 05, 2023 | Wednesday | News
Biogen's New Data Highlights SPINRAZA® Benefit in Infants and Toddlers after Gene Therapy

Interim results from the RESPOND study show improved motor function in most participants treated with SPINRAZA after Zolgensma® (onasemnogene abeparv...

July 03, 2023 | Monday | News
Celmatix Announces Breakthrough in Novel Oral Fertility Drug Program

-Celmatix Inc., the leading women’s health biotechnology company focused on ovarian biology, today announced the identification of promising early le...

June 29, 2023 | Thursday | News
FDA Approves Pfizer's NGENLA™, Weekly Treatment for Pediatric Growth Hormone Deficiency

Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon...

June 29, 2023 | Thursday | News
Cleveland Diagnostics Opens New Facility Amid Growing Demand for IsoPSA® Test

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, has o...

June 29, 2023 | Thursday | News
Bayer initiates Phase III studies with investigational contrast agent gadoquatrane

Gadoquatrane is a highly stable contrast agent for magnetic resonance imaging (MRI) with high relaxivity and the potential of a substantially lower gadol...

June 28, 2023 | Wednesday | News
Genmab and AbbVie Report Positive Results from EPCORE™ NHL-1 Trial for Epcoritamab in Relapsed/Refractory Follicular Lymphoma

Based on the topline results from the EPCORE™ NHL-1 clinical trial, Genmab and AbbVie will engage with global regulatory authorities to discuss nex...

June 28, 2023 | Wednesday | News
Kalos Medical's DENEX Hypertension Treatment System Earns Korean MFDS Innovative Medical Device Designation

The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted in...

June 28, 2023 | Wednesday | News
Diatech Pharmacogenetics Announces New Collaboration to Advance Precision Testing in Oncology

Diatech Pharmacogenetics (“Diatech”) has established a collaboration agreement with Janssen Pharmaceutica NV with the aim of improving access t...

June 21, 2023 | Wednesday | News
FDA Pilot Program Aims to Reduce Risks of Cancer Biomarker Tests

U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagn...

June 21, 2023 | Wednesday | News
FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes

"Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidl...

June 21, 2023 | Wednesday | News
Emgality Shows Promising Results in Landmark Migraine Prevention Trial, Says Eli Lilly Study

Emgality demonstrated robust efficacy for patients consistent with previous studies, although it did not achieve statistical superiority versus active comp...

June 17, 2023 | Saturday | News

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