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
Neuronetics Receives 510(k) Clearance for OCD MT Cap for NeuroStar Advanced Therapy

Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life fo...

June 13, 2023 | Tuesday | News
Stay Informed: FDA Roundup for June 9, 2023

FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to ...

June 12, 2023 | Monday | News
FDA Committee Unanimously Recommends Nirsevimab as First RSV Immunization for Infants

Nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, if approved Across all clinical ...

June 09, 2023 | Friday | News
Agilent Announces Full Workflow for US EPA Method 1633 for Targeted PFAS Analysis

Agilent Technologies Inc. (NYSE: A) announced today a highly-anticipated, complete workflow solution for targeted per- and polyfluoroalkyl substances (PFAS...

June 07, 2023 | Wednesday | News
Janssen Seeks FDA Approval for CARVYKTI® in Early Treatment of Multiple Myeloma

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progre...

June 07, 2023 | Wednesday | News
Ascentage Pharma's Olverembatinib Recommended for Second Breakthrough Therapy Designation in China for SDH-Deficient GIST

This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase c...

May 31, 2023 | Wednesday | News

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