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FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedeli...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
ZEISS Accelerates Validation Process for Coordinate Measuring Machines to Achieve FDA Compliance

Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software an...

June 23, 2023 | Friday | News
FBI Approves QIAGEN's ForenSeq MainstAY Workflow for U.S. DNA Index System

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that the U.S. Federal Bureau of Investigation (FBI) has approved its ForenSeq® Mains...

June 22, 2023 | Thursday | News
BioCardia's CardiAMP Cell Therapy for Heart Failure Receives FDA Review Completion

Under the adaptive statistical analysis plan, should the CardiAMP Cell Therapy for Heart Failure study be stopped early for anticipated efficacy at this, o...

June 22, 2023 | Thursday | 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
Novo Nordisk Acts to Safeguard US Patients from Illegal Sales of Non-FDA Approved Semaglutide Medicines

Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist fr...

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
Arcellx Announces Clinical Hold for its iMMagine-1 Phase 2 Clinical Program

Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with canc...

June 20, 2023 | Tuesday | News
FDA Approves Roche's Columvi: Groundbreaking Fixed-Duration Treatment for Diffuse Large B-cell Lymphoma

Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1...

June 19, 2023 | Monday | News
Biotech Executive Michael Smith Discusses the FDA Drug Development Process with CancerVAX CEO Ryan Davies

CancerVAX, Inc., developer of a breakthrough universal cancer vaccine that uses the body’s immune system to fight cancer,  announced that its CE...

June 19, 2023 | Monday | News
TG ImmunoPharma Announces FDA Clearance for Clinical Trial of TGI-6 Bispecific Antibody

TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, is pleased to announce that the F...

June 17, 2023 | Saturday | News
Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure

INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to ...

June 16, 2023 | Friday | News

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