News about Quality / GMP

DIFF Biotech's Nasal Spray Influenza Vaccine Receives Clinical Trial Approval

As the first domestically self-developed nasal spray influenza vaccine in China to advance into clinical trial, DIFF-flu, manufactured by DIFF Biotech, leverages a pioneering M2 gene–modified attenuation technology, protected by multiple international invention patents.

Quality / GMP | 10/02/2026 | By News Bureau |  139

Akeso Secures Fifth NMPA Breakthrough Designation for Ivonescimab

The breakthrough designation supports ivonescimab combined with chemotherapy for first-line treatment of advanced Biliary Tract Cancer (BTC), based on an ongoing phase-III study comparing it with durvalumab-based chemotherapy.

Quality / GMP | 07/02/2026 | By News Bureau |  358

PharmaResearch Wins FDA Clearance for Phase-I Trial of PRD-101

PRD-101 is a next-generation nano anti-cancer drug candidate formulated using nucleotide fragments produced through PharmaResearch's proprietary DOT (DNA Optimising Technology).

Quality / GMP | 07/02/2026 | By News Bureau |  238

Zydus Gets USFDA Tentative Nod for Dapagliflozin Tablets

Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for dapagliflozin tablets in 5 mg and 10 mg strengths, paving the way for the company’s entry into the US market subject to final approval.

Quality / GMP | 06/02/2026 | By News Bureau |  204

US FDA Grants Orphan Drug Designation to IFx-2.0 of TuHURA Biosciences

TuHURA Biosciences has received FDA Orphan Drug Designation for IFx-2.0 to treat stage IIB–IV cutaneous melanoma, based on data from its completed Phase I study published in Molecular Therapeutics.

Quality / GMP | 04/02/2026 | By News Bureau |  187

CHMP Recommends Imfinzi for Early Gastric Cancers

The EU’s CHMP has recommended approval of AstraZeneca’s Imfinzi perioperative regimen for early gastric and gastroesophageal cancers following positive phase-III MATTERHORN data, showing a 29 percent reduction in progression or recurrence risk and a 22 percent reduction in mortality versus chemotherapy alone.

Quality / GMP | 04/02/2026 | By News Bureau |  245

Pharming Gets Complete Response Letter from US FDA for Joenja

The US FDA issued a Complete Response Letter to Pharming Group for the supplemental NDA for Joenja, citing the need for additional information to support its use in children aged four to 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.

Quality / GMP | 02/02/2026 | By News Bureau |  246

J&J Wins CHMP Nod for AKEEGA in BRCA-Mutated mHSPC

Backed by positive AMPLITUDE trial results, the CHMP opinion supports AKEEGA in BRCA-mutated mHSPC, showing delayed disease progression and early signs of improved Overall Survival (OS) versus standard of care.

Quality / GMP | 02/02/2026 | By News Bureau |  161

EU recommends Rezurock for CHMP approval to treat chronic GVHD

The CHMP’s positive opinion, backed by clinical trial data and real-world evidence, paves the way for Rezurock’s potential approval in the EU as a new treatment option for adult and paediatric patients aged 12 years and above with late-line chronic graft-vs-host disease.

Quality / GMP | 02/02/2026 | By News Bureau |  163

Life Biosciences Wins FDA IND Clearance for ER-100

The IND clearance allows Life Bio to initiate a clinical programme evaluating ER-100’s safety and potential to improve vision in patients with optic neuropathies.

Quality / GMP | 29/01/2026 | By News Bureau |  2962