Advanced FDA Cleared Magstim Horizon 3.0 TMS Now Available in United Kingdom

The advanced and FDA-cleared Magstim Horizon 3.0 transcranial magnetic stimulation (TMS) system is now UKCA registered and available for sale in the UK, pr...

July 10, 2023 | Monday | News
HUTCHMED Begins Phase I Study of Novel SHP2 Inhibitor for Advanced Solid Tumors in China

The clinical trial is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-415 ...

July 10, 2023 | Monday | News
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
FDA Grants Orphan Drug Designation to ImPact Biotech's Padeliporfin VTP for Pancreatic Cancer

Designation confers advantages including marketing exclusivity and tax credits  Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start b...

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
Entourage Health Announces International Sale of Bulk Medical Cannabis to Australia

Company also issues Deferred Share Units to Board of Directors as Quarterly Director’s Remuneration Entourage Health Corp. (TSX-V: ENTG) (...

July 05, 2023 | Wednesday | News
Looking for [Process] Validation in All the Right Places

With an effective process validation regimen – with proper documentation and protocol testing to address product identity, strength, quality, purity,...

July 04, 2023 | Tuesday | News
India Takes Historic Step Towards Eliminating Animal Testing in Drug Development

New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especi...

July 01, 2023 | Saturday | 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
Theriva Biologics Receives FDA Orphan Drug Designation for VCN-01 in Pancreatic Cancer Treatment

In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy...

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
IQVIA Launches RIM Smart Labeling for Intelligent Global Label Management.

RIM Smart Labeling is part of IQVIA’s suite of purpose-built regulatory, safety and quality technology solutions and services. Label management is an...

June 27, 2023 | Tuesday | News
Bristol Myers Squibb Gets European Commission Approval for CAMZYOS® in Treating Symptomatic Obstructive HCM

CAMZYOS is the first and only cardiac myosin inhibitor approved in the European Union Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALO...

June 27, 2023 | Tuesday | News
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedeli...

June 26, 2023 | Monday | Regulatory

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