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
Soliris Approved in China for Refractory Myasthenia Gravis Treatment

Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetyl...

June 15, 2023 | Thursday | News
FDA Approves Bylvay® for Alagille Syndrome's Cholestatic Pruritus

Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related ...

June 14, 2023 | Wednesday | News
Croma-Pharma announces enrollment of first patient in hyaluronic acid dermal filler clinical trial in China

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial1 is being led by Lanhzou Biotechnique Development  wi...

June 13, 2023 | Tuesday | News

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2025 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close