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
Emergent BioSolutions Receives FDA Approval for CYFENDUS™, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorb...

July 21, 2023 | Friday | News
NANOBIOTIX Initiates Phase 1/2 Study of NBTXR3 Plus Anti-PD-1 in Advanced Cancers

Announced that the first patient has been injected in a Phase 1/2 study evaluating NBTXR3 activated by radiation therapy in combination with anti-PD-1/L-1 ...

July 20, 2023 | Thursday | News
HUTCHMED's Fruquintinib Combo Receives Breakthrough Designation in China for Advanced Endometrial Cancer, Enrollment Complete

It is a multi-center, open-label clinical study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab. Entry criteria include ...

July 20, 2023 | Thursday | News
Junshi Biosciences' Toripalimab Accepted for First-line Treatment of Extensive-stage Small Cell Lung Cancer

According to data released by GLOBOCAN 2020, lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small ce...

July 20, 2023 | Thursday | News
Karyopharm Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis

Regulatory Designation Includes Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis – &ndas...

July 18, 2023 | Tuesday | Regulatory

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