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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 | 144
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
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 | 104
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 | 102
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 | 102
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 | 100
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 | 160
MHRA Clears Deuruxolitinib (Leqselvi) by Sun Pharma for Severe Alopecia Areata in Adults
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) for treating severe Alopecia Areata in adults, granting authorisation to Sun Pharma UK via the International Recognition Procedure (IRP).
Quality / GMP | 13/03/2026 | By News Bureau | 106
EDQM Audit Finds Anuh Pharma Facility Compliant
Anuh Pharma has cleared a Good Manufacturing Practice (GMP) milestone following a successful audit by the European Directorate for the Quality of Medicines & HealthCare at its bulk drug manufacturing facility in Tarapur, Maharashtra, the company said in a stock exchange filing.
Quality / GMP | 11/03/2026 | By News Bureau | 113
US FDA Clears Sotyktu for Active Psoriatic Arthritis
The US Food and Drug Administration (FDA) has approved Sotyktu, developed by Bristol Myers Squibb, for adults with active psoriatic arthritis. The once-daily oral TYK2 inhibitor showed significantly higher ACR20 response rates versus placebo in the phase-III POETYK PsA-1 and PsA-2 trials.
Quality / GMP | 07/03/2026 | By News Bureau | 114
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