News about Quality / GMP

Atossa Therapeutics Receives FDA Orphan Drug Designation for Duchenne Therapy

Atossa Therapeutics has received US Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy, further supporting the company’s development programme in rare paediatric neuromuscular diseases.

Quality / GMP | 17/01/2026 | By News Bureau |  126

Organon Wins FDA Approval to Extend Duration of Use for NEXPLANON

Organon has received US Food and Drug Administration (FDA) approval for a supplemental New Drug Application extending the duration of use of NEXPLANON, its etonogestrel radiopaque contraceptive implant, to up to five years, expanding the product’s earlier three-year indication and offering longer-lasting contraceptive protection.

Quality / GMP | 17/01/2026 | By News Bureau |  446

Bionpharma Wins FDA Approval for Etravirine Tablets in Partnership with STEERLife

The US FDA approval clears the way for Bionpharma to market its generic Etravirine tablets in the US, expanding patient access to a cost-effective HIV treatment option.

Quality / GMP | 14/01/2026 | By News Bureau |  149

Biocon Receives US FDA Approval for Everolimus Tablets for Oral Suspension

Biocon has secured US FDA approval for Everolimus Tablets for Oral Suspension, enhancing its portfolio of vertically integrated drug products and expanding treatment options for patients in key markets.

Quality / GMP | 13/01/2026 | By News Bureau |  150

Alembic Pharma Secures US FDA Tentative Approval for Bosutinib Tablets

The USFDA’s tentative approval confirms that Alembic Pharmaceuticals’ Bosutinib Tablets, 400 mg, meet therapeutic equivalence requirements with the Reference Listed Drug (RLD) Bosulif, marking an important step towards potential market entry.

Quality / GMP | 12/01/2026 | By News Bureau |  184

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.

Quality / GMP | 09/01/2026 | By News Bureau |  146

US FDA Grants Orphan Drug Designation to CK0804 Treg Therapy of Cellenkos

The US FDA has granted Orphan Drug Designation to Cellenkos’ CK0804, a first-in-class CXCR4hi Treg therapy for myelofibrosis. The investigational therapy is designed to home to the bone marrow and spleen, where it modulates inflammation through in-vivo expansion and IL-10 secretion.

Quality / GMP | 07/01/2026 | By News Bureau |  147

Atossa Therapeutics Receives FDA Go-Ahead for (Z)-Endoxifen IND in Metastatic Breast Cancer

Atossa Therapeutics announced that it has received a “Study May Proceed” letter from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for (Z)-endoxifen in metastatic breast cancer, clearing the way for the initiation of clinical studies evaluating the therapy.

Quality / GMP | 07/01/2026 | By News Bureau |  229

Ascletis Receives FDA IND Clearance for Phase II ASC30 Diabetes Study

Ascletis has received US FDA IND clearance to initiate a 13-week phase-II, randomised, double-blind, placebo-controlled, multi-centre study evaluating the efficacy, safety and tolerability of its oral small-molecule GLP-1 candidate ASC30 in participants with diabetes, with enrollment expected to begin in the first quarter of 2026.

Quality / GMP | 05/01/2026 | By News Bureau |  141

ScinoPharm Wins FDA Approval for Glatiramer Acetate Injection

ScinoPharm Taiwan has received US FDA approval for its Glatiramer Acetate Injection for the treatment of multiple sclerosis, marking a significant milestone as the first and only Taiwanese pharmaceutical company to secure FDA approval for this complex generic, and reinforcing Taiwan’s growing role in the global pharmaceutical supply chain.

Quality / GMP | 05/01/2026 | By News Bureau |  151