FDA Approves First Oral Treatment for Postpartum Depression

"Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in sever...

August 07, 2023 | Monday | News
ImPact Biotech Gets FDA Clearance for Padeliporfin VTP Phase 1 in Lung Cancer

 ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administrat...

August 07, 2023 | Monday | News
Etiometry's AI Algorithm FDA Cleared to Alert Neonatal Hypercapnia Risk

Etiometry, the leader in clinical decision-support software, announced today its IVCO2 Index™was cleared by the Food and Drug Administration for use ...

August 03, 2023 | Thursday | News
Molecular Targeting Technologies and Singapore's Theranostics Center Gain HSA Approval for EBTATE® Trial in Nasopharyngeal Cancer

Somatostatin receptor 2 (SSTR2) is found in 81% of primary, recurrent, and metastatic NPC patients. EBTATE, the first patented and only long-acting peptide...

August 03, 2023 | Thursday | News
China's NMPA Accepts Astellas' Zolbetuximab Biologics License Application

Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas"China accounts for nearly half of...

August 01, 2023 | Tuesday | News
Amarin and Lotus Pharmaceuticals Partner to Commercialize Vazkepa® in Southeast Asia and South Korea

Amarin Corporation plc (NASDAQ:AMRN) and Lotus Pharmaceuticals (1795:TT; “Lotus”)  announced that the two companies have entered into a lo...

August 01, 2023 | Tuesday | News
Spero Therapeutics and FDA Agree on Phase 3 PIVOT-PO Trial for Tebipenem HBr

Spero to receive $30 million development milestone payment from GSK Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutica...

August 01, 2023 | Tuesday | News
FDA Streamlines Innovation for Opioid Use Disorder Devices

"The FDA continues to seek new ways to advance science to address the public health challenges that families and communities across the country face," said...

July 28, 2023 | Friday | News
EmVenio Research & TrialHub Partner to Boost Clinical Trial Efficiency

Through TrialHub's data intelligence gathering platform, EmVenio can easily identify optimal markets to attract clinical trial participants who are needed ...

July 28, 2023 | Friday | News
WuXi Vaccines' First Drug Substance Facility in China Now GMP-Ready

The GMP release of its first DS facility in China enhances WuXi Vaccines' capability in providing global partners with comprehensive end-to-end solutions, ...

July 28, 2023 | Friday | News
Bharat Serums and Vaccines Initiates Compliance Measures for Assisted Reproduction Methods

India based biopharmaceutical firm Bharat Serums and Vaccines has roped in Bureau Veritas (India) Pvt. Ltd. (BVIL), a world leader in Audit and Certificati...

July 26, 2023 | Wednesday | News
AstraZeneca's Dapagliflozin Receives Expanded Approval for Heart Failure Treatment in India

AstraZeneca Pharma India has received extended indication approval from the Drugs Controller General of India (DCGI) for its drug, Dapagliflozin in the tre...

July 25, 2023 | Tuesday | News
Menarini Group Receives Positive CHMP Opinion for ORSERDU® in ER+ Metastatic Breast Cancer

Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease¹; more tha...

July 24, 2023 | Monday | News
BeiGene's Tislelizumab Receives Positive CHMP Opinion for Advanced ESCC Treatment

“Tislelizumab is the first medicine to come from BeiGene’s immuno-oncology research program and our team partnered with patients, caregivers, a...

July 24, 2023 | Monday | News

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