Last edition
News about Regulation
Ono Pharmaceuticals Gets Nod for XCOPRI Tablets in Japan
Ono has received manufacturing and marketing approval in Japan for XCOPRI tablets to treat partial-onset seizures, with or without secondary generalisation.
Regulation | 18/09/2026 | By News Bureau | 141
US FDA Approves DifGen's Epinephrine Injection, 1 mg/mL
DifGen gets US FDA approval for Epinephrine Injection USP 1 mg/mL, its second generic to Adrenalin, expanding its injectable portfolio.
Regulation | 18/09/2026 | By News Bureau
Govt Issues Advisory on Stem Cell Therapy Regulation
Health Ministry permits stem cell therapy only for approved conditions, limits ASD treatment to trials, and bars unproven use as routine care.
Regulation | 18/09/2026 | By News Bureau | 123
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 | 101
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 | 108
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 | 115
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy