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
Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Systemic Lupus Erythematosus

CABA-201 data package and experience from prior autoimmune cell therapy INDs informed Phase 1/2 clinical trial design, including the initial dose to be eva...

March 31, 2023 | Friday | News
NEC Establishes Subsidiaries in Europe for Strengthening Global AI Drug Development Business

Today, NEC and NOI announced that NOI will be realigned as a subsidiary of NEC Bio B.V. (NB) in Hilversum, Netherlands, a newly established wholly owned su...

March 31, 2023 | Friday | News
COVID-19 Infection Shown to Significantly Increase Drug Clearance of Therapeutic Monoclonal Antibodies

Patients with inflammatory diseases being treated with therapeutic monoclonal antibodies (mAbs) such as Infliximab may experience a significant increase in...

March 30, 2023 | Thursday | News
TandemAI launches TandemViz™ 1.0 - a web-based GUI for integrated computational analysis and experimental data

TandemAI today announced the release of TandemViz™ 1.0, the company’s proprietary web-based platform that provides its growing roster of drug d...

March 29, 2023 | Wednesday | News
Sanofi receives marketing approval for its diabetes drug Soliqua™ in India

Sanofi (India) announced that it has received marketing authorization for its diabetes drug Soliqua™ (in pre-...

March 28, 2023 | Tuesday | Regulatory

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