News about Quality / GMP

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 |  140

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 |  139

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 |  147

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 |  186

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 |  113

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 |  117

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 |  2147

Immix Biopharma Gets US FDA Breakthrough Therapy Designation for NXC-201

Immix Biopharma has received US FDA Breakthrough Therapy Designation for its CAR-T candidate NXC-201, based on positive interim phase-II results from the NEXICART-2 study presented at the ASH 2025 annual meeting, with final data expected later this year followed by a planned Biologics Licence Application (BLA) submission.

Quality / GMP | 29/01/2026 | By News Bureau |  145

Sun Pharma Wins DCGI Nod for Generic Semaglutide Injection

Sun Pharmaceutical has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic semaglutide injection for chronic weight management, paving the way for its entry into the fast-growing obesity treatment segment once the semaglutide patent expires in the country.

Quality / GMP | 27/01/2026 | By News Bureau |  200

China Approves Trelegy Ellipta for Uncontrolled Asthma

China has approved Trelegy Ellipta for adults with uncontrolled asthma, extending its use beyond COPD and making it the only single-inhaler triple therapy for both conditions in the country.

Quality / GMP | 27/01/2026 | By News Bureau |  191