News about Quality / GMP

Denali Therapeutics Wins FDA Approval for AVLAYAH in Hunter Syndrome

US FDA approves Denali Therapeutics’ AVLAYAH for Hunter syndrome (MPS II), the first new treatment in nearly 20 years and a novel biotherapeutic designed to cross the blood-brain barrier.

Quality / GMP | 26/03/2026 | By News Bureau |  132

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.

Quality / GMP | 25/03/2026 | By News Bureau |  148

Viatris Secures Japan Approval for Effexor SR as First Treatment for Generalised Anxiety Disorder

Japan’s health ministry approves Effexor SR for adult GAD, marking the first and only authorised treatment in the country and expanding access to mental health care.

Quality / GMP | 24/03/2026 | By News Bureau |  177

Galderma Wins FDA Approval for Restylane Contour for Temple Hollowing

FDA approves Galderma’s Restylane Contour for temple hollowing, expanding its use with natural-looking results lasting up to 18 months and high patient satisfaction.

Quality / GMP | 24/03/2026 | By News Bureau |  124

GSK plc Secures Japan Orphan Drug Status for Ris-Rez in Small-Cell Lung Cancer

Japan’s health ministry grants orphan drug designation to GSK’s investigational ADC Ris-Rez for SCLC, supported by early clinical data showing durable responses in advanced-stage patients.

Quality / GMP | 24/03/2026 | By News Bureau |  186

FDA Accepts Ionis' Zilganersen NDA for Priority Review in AxD

Ionis’ zilganersen NDA for Alexander disease has been accepted by the FDA for Priority Review, with a PDUFA target action date set for 22nd September, 2026, marking a key regulatory milestone for the potential treatment.

Quality / GMP | 24/03/2026 | By News Bureau |  246

Belief Pharmaceuticals' Haemophilia B Gene Therapy Approved in Macau

Macau approves Belief Pharmaceuticals’ Popedacoq gene therapy for haemophilia B, marking regional expansion after China approval and advancing access to one-time treatment solutions.

Quality / GMP | 23/03/2026 | By News Bureau |  113

Novo Nordisk Wins FDA Approval for Wegovy HD to Advance Obesity Treatment

FDA approves Novo Nordisk’s Wegovy HD (semaglutide 7.2 mg), a higher-dose weekly injection delivering significant weight loss, supported by strong Phase III trial outcomes.

Quality / GMP | 21/03/2026 | By News Bureau |  178

GSK Secures FDA Approval for Lynavoy, First Treatment for PBC-Related Chronic Itch

FDA approves GSK’s Lynavoy (linerixibat), the first therapy for cholestatic pruritus in primary biliary cholangitis patients, offering significant and sustained itch relief.

Quality / GMP | 21/03/2026 | By News Bureau |  188

Johnson & Johnson Secures FDA Approval for Icotyde, First Oral IL-23 Inhibitor for Psoriasis

FDA approves Johnson & Johnson’s Icotyde, a first-in-class oral IL-23 receptor antagonist, offering a once-daily treatment option for moderate-to-severe plaque psoriasis in adults and adolescents.

Quality / GMP | 20/03/2026 | By News Bureau |  359