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Japan Approves Lundbeck's Vyepti for Migraine Prevention
Lundbeck's Vyepti (eptinezumab) gains Japan approval for migraine prevention, the only IV CGRP-targeted preventive treatment, now in 30+ countries.
Regulation | 17/09/2026 | By News Bureau
Health Ministry Moves to Tighten Schedule H, H1 and X Drugs
Health Ministry proposes stricter Schedule H, H1, X drug oversight and mandatory CCTV surveillance at medical stores for transparency.
Regulation | 17/09/2026 | By News Bureau
Aurobindo Pharma receives US Food and Drug Administration (FDA) final approval for Beclomethasone Dipropionate HFA Inhalation Aerosol, marking its first Metered-Dose Inhaler (MDI) product and expanding its complex respiratory portfolio.
Regulation | 16/09/2026 | By News Bureau
US FDA Approves Reduced Monitoring Time for First 2 Doses of Imdelltra
The US Food and Drug Administration (FDA) has approved reduced monitoring time for the first 2 doses of Imdelltra, supporting broader community access for patients with extensive-stage Small Cell Lung Cancer (SCLC).
Regulation | 15/09/2026 | By News Bureau
US FDA Accepts NDA under Priority Review for Takeda's Zasocitinib
The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) for zasocitinib under Priority Review (PR) for the treatment of moderate-to-severe plaque psoriasis, potentially redefining expectations for oral treatment.
Regulation | 15/09/2026 | By News Bureau
US FDA Grants Orphan Drug Designation to Lundbeck's Asedebart for Cushing's Syndrome
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Lundbeck’s investigational anti-ACTH antibody asedebart for endogenous Cushing’s syndrome; a proof-of-concept trial is ongoing.
Regulation | 14/09/2026 | By News Bureau
US FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
The US Food and Drug Administration (FDA) has approved Isembyld, the first therapy for Spinal Muscular Atrophy (SMA) that directly targets muscle loss alongside existing treatments.
Regulation | 14/09/2026 | By News Bureau
US FDA Grants Priority Review to Genentech?s Enspryng for MOGAD
The US Food and Drug Administration (FDA) has granted priority review to Genentech’s Enspryng for MOGAD after phase 3 METEOROID data showed a 68 percent reduction in relapse risk.
Regulation | 11/09/2026 | By News Bureau
US FDA Grants Accelerated Approval to Sevabertinib for Advanced NSCLC
The US Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with HER2 (ERBB2) TKD activating mutations.
Regulation | 11/09/2026 | By News Bureau
The Central Drugs Standard Control Organisation (CDSCO) signals smarter, risk-based pharma regulation at iPHEX 2026, calling for proportionate enforcement, simpler compliance and clearer regulatory norms.
Regulation | 09/09/2026 | By News Bureau
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