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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 | 236
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 | 434
FDA Approves Rhythm Pharma's IMCIVREE for Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals has received US Food and Drug Administration (FDA) approval for IMCIVREE, the first and only treatment for acquired Hypothalamic Obesity (HO), supported by phase-III data showing a 18.4 percent placebo-adjusted BMI reduction in patients aged four years and older.
Quality / GMP | 20/03/2026 | By News Bureau | 223
Sanofi Secures FDA Breakthrough Designation for Rare Disease Therapy
Sanofi has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational drug venglustat, aimed at treating neurological symptoms associated with type 3 Gaucher disease (GD3).
Quality / GMP | 19/03/2026 | By Darshana | 215
CDSCO Approves AstraZeneca Pharma India's Durvalumab for uHCC Treatment
AstraZeneca Pharma India has received CDSCO approval for durvalumab to treat unresectable hepatocellular carcinoma (uHCC), a major global health concern as HCC ranks among the most common and deadliest cancers worldwide.
Quality / GMP | 18/03/2026 | By Akanki | 182
EU Approves Imfinzi as First Perioperative Immunotherapy for Gastric and Gastroesophageal Cancers
The EU approval of Imfinzi is based on phase-III MATTERHORN trial results, which showed significant improvements in event-free and overall survival in early-stage gastric and gastroesophageal cancer patients.
Quality / GMP | 17/03/2026 | By Akanki | 167
The US FDA has accepted Sun Pharma’s supplemental BLA for ILUMYA to treat active psoriatic arthritis in adults, with a decision expected by 29 October, 2026, potentially expanding its IL-23 inhibitor portfolio.
Quality / GMP | 17/03/2026 | By News Bureau | 233
US FDA Approves GSK's AREXVY for At-Risk Adults Aged 18 to 49 Years
The US FDA has approved GSK’s RSV vaccine, AREXVY, for adults aged 18–49 who are at increased risk of severe RSV infection, expanding protection to an estimated 21 million at-risk individuals in this age group.
Quality / GMP | 16/03/2026 | By News Bureau | 162
US FDA Approves Novartis' Cosentyx for Adolescents with Moderate-to-Severe Hidradenitis Suppurativa
The FDA has approved Novartis’ Cosentyx for patients aged 12 years and above with moderate-to-severe Hidradenitis Suppurativa (HS), marking the therapy’s fourth paediatric indication and expanding treatment options with a differentiated IL-17A mechanism.
Quality / GMP | 16/03/2026 | By News Bureau | 221
US FDA Approves Zydus' Cevimeline Hydrochloride Capsules 30 mg
Zydus Lifesciences has received USFDA approval for Cevimeline Hydrochloride Capsules 30 mg for treating dry mouth associated with Sjögren’s syndrome. The capsules will be manufactured at the company’s SEZ-II facility in Ahmedabad.
Quality / GMP | 13/03/2026 | By News Bureau | 253
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