Business, energy, technology, markets and global industry news from Business News Today

Skip to content

Home
Pharma & Biotech
Medical Devices & Diagnostics
Features & Analysis

Home
Pharma & Biotech
Medical Devices & Diagnostics
Features & Analysis

Japan drug approval

PharmaDeviceNews Japan drug approval

Representative image illustrating the global expansion of phenylketonuria treatment, reflecting Japan’s approval of Sephience by PTC Therapeutics and the growing international reach of rare disease therapies.

Pharma & Biotech

PTC Therapeutics receives Japanese approval for Sephience in full-spectrum PKU

by Venkatesh B
December 22, 2025
0 Comments

Japan approves Sephience for PKU across all ages. Find out what this means for PTC Therapeutics' global rare disease expansion strategy.

Read More

Latest news and features

Aravax FDA fast-track win moves PVX108 closer to its defining peanut allergy test
Can Dash Bio’s $30m automation bet break one of drug development’s slowest bottlenecks?
What the Obsidian Therapeutics and Galera Therapeutics merger means for OBX-115
GE HealthCare expands dense breast screening portfolio with Invenia ABUS Prime and ABUS StreamVue
Cizzle Bio’s South Texas laboratory deal widens CIZ1B reach, but the real test starts now
What FDA’s latest ibezapolstat guidance means for Acurx and the IBZ-ASPIRE trial
Lilly’s rare pancreatic cancer target just gained FDA momentum, but olomorasib still faces its hardest test
Can Invenio Imaging’s AI deliver reliable lung biopsy feedback inside the bronchoscopy room?
AusperBio has entered the HBV siRNA race, but can AHB-171 move beyond antigen suppression?
Incyte’s Minjuvi gains Australian reimbursement after TGA follicular lymphoma registration
Mezzion’s new kidney disease data sent shares higher, but the decisive test is still ahead
GlycoNex has taken GNX1021 into humans, but its bold glycan-targeting theory now faces the real test

POPULAR NEWS

Niagen Bioscience’s NB4168 has secured U.S. FDA Rare Pediatric Disease and European orphan designations as the company advances the experimental ataxia telangiectasia therapy toward human trials. Representative image.

Pharma & Biotech

Niagen wins twin rare-disease designations, but can NB4168 turn nicotinamide riboside evidence into a medicine?

July 14, 2026

Representative image of a clinician reviewing skeletal imaging, illustrating Mirum Pharmaceuticals and Incyte’s zilurgisertib Phase 2 progress in fibrodysplasia ossificans progressiva and the rare disease treatment questions facing regulators.

Pharma & Biotech

Why Mirum Pharmaceuticals and Incyte’s zilurgisertib data could reset expectations in FOP treatment

June 15, 2026

Representative image of biopharma laboratory research. Gilead Sciences and Merck’s latest Phase 3 updates highlight the promise of once-weekly HIV treatment with islatravir and lenacapavir, while raising fresh questions over Trodelvy’s lung cancer expansion strategy.

Pharma & Biotech

Gilead and Merck pipeline update reveals promise in HIV and pressure in oncology

June 9, 2026

Latest business and industry news

Brookfield completes $3bn Oaktree buyout as credit platform reaches $365 bn
Williams to buy Momentum Midstream for $5.5bn as Haynesville LNG strategy accelerates
Snap revenue jumps 19% as AI advertising tools revive $SNAP investor confidence
Control Bionics (ASX: CBL) registers NeuroStrip with US FDA as commercial execution becomes the next test
Flotek secures 10-year Puerto Rico power role as $400m backlog tests PWRtek strategy

TAGS

clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

About PharmaDeviceNews
Disclaimer
Editorial Policy
Privacy Policy
Contact Us

© 2026 PharmaDeviceNews.com. All rights reserved.