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.

BioPharma Accord, Inc. reports the U.S. FDA has greenlit their application for a license regarding their proposed biosimilar to STELARA®, named DMB-3115.

Innate Pharma has been given the green light by the FDA to resume its Lacutamab Clinical Program after the previous partial clinical hold was removed.