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07 Jan 2023 HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200603
07 Jan 2023 Dragonfly Therapeutics Announces Sixth Dragonfly TriNKET Opt-in by Bristol Myers Squibb
07 Jan 2023 Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
07 Jan 2023 FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
06 Jan 2023 U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine in Infants and Children
06 Jan 2023 Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)
06 Jan 2023 Mission Therapeutics Successfully Completes First Clinical Assessment for Lead DUB Program, MTX652
06 Jan 2023 ArsenalBio Announces First Patient Dosed in Phase 1 Clinical Trial of AB-1015 in Development as a Treatment for Ovarian Cancer
06 Jan 2023 Nimble Therapeutics Announces Expansion of its Discovery and Development Partnership with Genentech
06 Jan 2023 Graphite Bio Announces Voluntary Pause of Phase 1/2 CEDAR Study of nulabeglogene autogedtemcel (nula-cel) for Sickle Cell Disease
06 Jan 2023 Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration
06 Jan 2023 Fusion Pharmaceuticals and BWXT Medical Announce Actinium-225 Partnership to Scale Supply for Developing Targeted Alpha Therapies
06 Jan 2023 UCB announces rozanolixizumab BLA for the treatment of generalized myasthenia gravis filed with U.S. FDA and designated for Priority Review
06 Jan 2023 FDA Grants Priority Review to Genentech’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma
06 Jan 2023 CureVac Announces Positive Data on Joint COVID-19 and Flu mRNA Vaccine Development Programs
05 Jan 2023 CytomX and Moderna Announce Strategic Research Collaboration for mRNA-Based Conditionally Activated Therapeutics
05 Jan 2023 Fate Therapeutics Announces Termination of Collaboration Agreement with Janssen, Pipeline Prioritization, Next-Generation Programs, and Key 2023 Initiatives
05 Jan 2023 Takeda Announces Favorable Phase 3 Safety and Efficacy Results of TAK-755 as Compared to Standard of Care in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
05 Jan 2023 Synaffix Enters License Agreement with Amgen to Build Next Generation ADCs
05 Jan 2023 Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

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