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
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
First Patient Dosed in Telix's Phase II STARBURST Study Expanding TLX250-CDx Indication in Australia

The STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) is a prospective, open label Phase II "basket" study to investigate CAIX expression in pat...

June 19, 2023 | Monday | 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
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
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
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
Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility

Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s...

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
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
OnQuality's OQL051 Granted FDA Clearance for Chemotherapy-Induced Diarrhea Prophylaxis

CID is a common and often debilitating toxicity affecting up to 90% of patients receiving chemotherapy. CID can cause dehydration, electrolyte imbalance, m...

June 07, 2023 | Wednesday | News

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