News about Quality / GMP

US FDA Clears Anuh Pharma Facility with No Form 483 Observations

The Tarapur facility of Anuh Pharma is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate block with total capacity of 2400 MTPA.

Quality / GMP | 11/02/2026 | By News Bureau

China Grants Priority Review to Leqembi Subcutaneous BLA

The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.

Quality / GMP | 11/02/2026 | By News Bureau

Akums Receives First UK MHRA Approval for Rivaroxaban

Rivaroxaban is an oral anticoagulant prescribed for the prevention and treatment of thromboembolic disorders, including Non-Valvular Atrial Fibrillation (NVAF), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and clinically relevant cardiovascular risk reduction.

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

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

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

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

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

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

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

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