Adverse event (AE) refers to any adverse event that may occur to the subject in the clinical trial and may be related to the trial treatment and trial treatment.

UCB has revealed that the European Commission has sanctioned the use of RYSTIGGO (rozanolixizumab) for treating generalized myasthenia gravis in adult patients across Europe.

Innovent Biologics and Sanegene Bio (Suzhou) announced their partnership to co-develop SGB-3908, an siRNA drug targeting AGT for hypertension treatment.

OBI Pharma has disclosed that the FDA has given its approval for a Phase 1/2 clinical trial application concerning OBI-992, a TROP2 antibody-drug conjugate.

The trial protocol should strictly define what subjects can be enrolled (enrollment criteria) and what subjects cannot be enrolled (exclusion criteria).

Asklepios BioPharmaceutical, Inc., a wholly-owned subsidiary of Bayer AG, has launched Phase II of the GenePHIT trial to assess the effectiveness of its gene therapy drug AB-1002 (NAN-101) for congestive heart failure.

The latest 4-year follow-up data from C-144-01 on lifileucel’s treatment outcomes and patterns of response were reported in 2023 ESMO_IO.

Sana Biotech Reveals US Regulatory Approval for Experimental Drug SC262, an Engineered Immune-resistant, Targeted CD22 Allo CAR T Cell Treatment, Aimed at Individuals Suffering from Recurring or Resistant Types of B-cell Cancer.

There are no explicit provisions on the storage of test related documents. However, ichgcp stipulates the minimum filing documents - basic documents.

Boston Pharmaceuticals Unveils Research at the 2024 NASH-TAG Showing Sustained Low Immune Reaction to their Extended-release FGF21 Mimic, BOS-580, in MASH Management.

FXR agonists are drugs that activate the farnesoid X receptor, regulating bile acid synthesis and aiding in the treatment of liver and metabolic disorders.

Ligand Pharmaceuticals Inc. has announced FDA approval for ZELSUVMI™ (berdazimer topical gel, 10.3%), now approved to treat molluscum contagiosum in adults and children aged 1 and older.