News about Quality / GMP

Elanco Expands TruCan Vaccine Portfolio with USDA-Approved Oral Bordetella Shot

Elanco Animal Health Incorporated has received approval from the US Department of Agriculture (USDA) for TruCan Ultra B (Oral), a next-generation oral vaccine designed to protect dogs against Bordetella bronchiseptica, a key cause of canine infectious respiratory disease complex (CIRDC), commonly known as kennel cough.

Quality / GMP | 19/01/2026 | By Darshana |  272

FDA Acknowledges Pain Reduction Data Supporting Rexlemestrocel-L Efficacy

The US Food and Drug Administration (FDA) has acknowledged clinical data showing that Rexlemestrocel-L reduced pain intensity over 12 months, supporting the product’s efficacy in treating back pain. The agency also indicated that the approval label may include language related to opioid reduction.

Quality / GMP | 19/01/2026 | By News Bureau |  203

UK MHRA Approves up to 7.2 mg Dose of Semaglutide for Obesity Treatment

The UK MHRA has approved a higher dose of semaglutide of up to 7.2 mg for weight management in adult patients with obesity. The regimen involves three 2.4 mg injections and is indicated for use alongside a reduced-calorie diet and increased physical activity in adults with a Body Mass Index (BMI) of 30 kg/m² or higher.

Quality / GMP | 17/01/2026 | By News Bureau |  198

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 |  186

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 |  542

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 |  201

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 |  217

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 |  267

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 |  202

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 |  200