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FDA rejects Vanda’s jet lag drug in current form
Drug Approval | January 12, 2026

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning


Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera
News | January 11, 2026

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories


BeOne Medicines wins first-in-world nod for Sonrotoclax in China
Drug Approval | January 09, 2026

BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability


GSK secures European nod for easier-to-use Shingrix prefilled syringe
News | January 09, 2026

GSK secures European nod for easier-to-use Shingrix prefilled syringe

The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration


GSK’s Exdensur wins Japanese nod for severe asthma
Drug Approval | January 08, 2026

GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)


Lilly to buy Ventyx Biosciences for $1.2 billion
News | January 08, 2026

Lilly to buy Ventyx Biosciences for $1.2 billion

Ventyx's clinical pipeline includes multiple small molecules with potential for oral therapies addressing chronic inflammation


Rapid-acting ADHD treatment Azstarys now approved in China
Drug Approval | January 08, 2026

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood


Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
Medical Device | January 08, 2026

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures