Roche's Columvi Gets CHMP Nod for Fixed-Duration Use in Diffuse Large B-cell Lymphoma

The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete r...

April 27, 2023 | Thursday | Regulatory
AmerisourceBergen Launches Cell and Gene Therapy Integration Hub

-AmerisourceBergen, a global healthcare company, today announced the launch of its Cell and Gene Therapy (CGT) Integration Hub, a system that can be integr...

April 26, 2023 | Wednesday | News
Agilent and Theragen Bio collaborate to boost cancer genomic profiling through bioinformatic solutions in South Korea.

Agilent Technologies Inc. (NYSE: A) announced the recent signing of a Memorandum of Understanding (MOU) with Theragen Bio in South Korea to boos...

April 26, 2023 | Wednesday | News
Virios Therapeutics gets FDA feedback on IMC-1 Phase 3 program for Fibromyalgia treatment

-Virios’ IMC-1 Phase 3 Proposed Program is Considered Acceptable based on Initial FDA Feedback Pending Review of the Final Chronic Toxicology Program...

April 25, 2023 | Tuesday | News
Forge Biologics Receives QP Declaration for AAV Gene Therapy Manufacturing in Europe

Forge Biologics, a leading manufacturer of genetic medicines, today announced that its manufacturing facility has successfully completed the audits necessa...

April 24, 2023 | Monday | News
Aurisco Expands Oligonucleotide Capacity and Launches New Website

The New State-of-Art OligoPilot 2000™ solid-phase synthesizer adds cGMP manufacturing capacity to support and accelerate clinical and commercial olig...

April 24, 2023 | Monday | News
Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors

Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applyin...

April 21, 2023 | Friday | News
Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Announced an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT045...

April 19, 2023 | Wednesday | News
Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol. At th...

April 18, 2023 | Tuesday | News
Olaratumab Antibody Licensed from Lilly Demonstrates Proof of Concept as a Theranostic Radiopharmaceutical

In April 2022, Telix secured the exclusive worldwide rights to develop and commercialise radiolabelled forms of olaratumab for the diagnosis and treatment ...

April 17, 2023 | Monday | News
Atmo Biosciences strengthens U.S. focus with new board appointment and establishment of San Diego office

The increased presence in the U.S. comes as Atmo Biosciences prepares to begin a multi-site pivotal study to support a U.S. Food and Drug Administration (F...

April 17, 2023 | Monday | News
IPS HEART receives FDA Rare Pediatric Drug Designations for both of its Stem Cell Drugs for Duchenne Muscular Dystrophy

The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC. Current treatments for DMD have limited therapeutic potential as unfortunat...

April 14, 2023 | Friday | News
Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue

Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the init...

April 14, 2023 | Friday | News
Fusion Pharmaceuticals Announces IND Clearance for FPI-2068, a Jointly Developed Novel Targeted Alpha Therapy

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medic...

April 13, 2023 | Thursday | Regulatory

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