Covis Statement on FDA Decision to Withdraw Approval of Makena®

The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implem...

April 09, 2023 | Sunday | News
Cell Expansion Market Analysis

The rising prevalence of chronic diseases coupled with increasing research activities for cell-based research is found to be the major factor driving the...

April 07, 2023 | Friday | Analysis
Japan Drug Delivery Devices Market Analysis

Drug delivery devices help in delivering the drugs which are beneficial for the targeted population to recover faster. In addition, a rising number of ca...

April 07, 2023 | Friday | Analysis
Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA

Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the de...

April 06, 2023 | Thursday | News
Deka Biosciences Announces First-in-Human Dose in Phase 1 Clinical Trial of DK210 (EGFR)

he Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to...

April 06, 2023 | Thursday | News
Accord BioPharma's Biosimilar Trastuzumab HLX02 BLA Accepted by US FDA

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, ...

April 06, 2023 | Thursday | News
Everest Medicines Announces New Drug Application Acceptance by Singapore HSA

Nefecon NDA is currently under Priority Review in China and expected to receive approval in 2H 2023- Everest Medicines (HKEX 1952.HK, "...

April 06, 2023 | Thursday | News
Perfuse Therapeutics' PER-001 Intravitreal Implant clears FDA IND application for Glaucoma trial

Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the ...

April 05, 2023 | Wednesday | News
InflaRx's Gohibic (vilobelimab) receives FDA Emergency Use Authorization for critically ill COVID-19 patients

Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune ...

April 05, 2023 | Wednesday | News
Orbit Discovery and Evergreen Discovery Collaborate to Discover Peptides for Targeting Radiopharmaceuticals

-Evergreen Discovery (Evergreen), a leading radiopharmaceutical drug development company with a focus on the treatment and diagnosis of cancer, and Orbit D...

April 04, 2023 | Tuesday | News
FDA Grants Accelerated Approval for PADCEV® with KEYTRUDA® for Urothelial Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) announced the U.S. Food and Drug Administrati...

April 04, 2023 | Tuesday | News
Sanofi/Regeneron's Dupixent's Performance in Eosinophilic Esophagitis Sets Stage for Future Therapies: Spherix Global Insights

In 2017, Sanofi/Regeneron announced the FDA approval for the first biologic agent to treat atopic dermatitis (AD). The success of that drug, Dupixent (dupi...

April 04, 2023 | Tuesday | News
Galapagos and NovAliX enter into an integrated drug discovery collaboration

Galapagos to transfer drug discovery and research activities in Romainville, France to NovAliX, a drug-discovery focused Contract Research Organization (...

April 03, 2023 | Monday | News
Synthetic Periwinkle: Emulating Nature For Drug Discovery

With its resplendent flowers, the Madagascar periwinkle plant (Catharanthus roseus) easily draws attention to itself, both in a natural setting and in ...

April 01, 2023 | Saturday | Analysis

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