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2026-09-15 07:32:36
Hibsago (bepirovirsen), an GSK/Ionis antisense oligonucleotide, was approved in Japan for adult chronic hepatitis B functional cure. This page covers its ASO mechanism, 6-month subcutaneous regimen, pooled B-Well 1/2 functional cure rates, and safety notes on injection-site reactions and transaminases.
2026-09-15 07:24:01
In September 2026, the FDA approved Scholar Rock’s Isembyld (apitegromab-mstn) for Spinal Muscular Atrophy (SMA). As the first therapy targeting skeletal muscle, it offers a novel combination approach alongside SMN2-directed therapies for patients aged 2 and older.
2026-09-08 05:39:33
Mirogabalin is used for neuropathic pain, but its analgesic effect is not immediate. This article explains dose titration, factors affecting onset, and the need for continuous observation.
2026-09-07 04:57:52
FDA approved Zanvastro intrathecal injection in September 2026 as the first disease-modifying drug for Alexander disease. This article covers its ASO mechanism, all-age indication, clinical trial efficacy, and safety guidelines.
2026-08-31 02:30:28
On August 27, 2026, the FDA approved once-daily oral brepocitinib 30 mg for adults with dermatomyositis — the first targeted and first oral therapy ever approved for the disease.
2026-08-28 06:51:52
In August 2026, the U.S. FDA granted accelerated approval to daraxonrasib (Rasonque), an oral RAS(ON) inhibitor developed by Revolution Medicines. The drug significantly improves survival in metastatic pancreatic cancer, reshaping the treatment landscape.
2026-08-27 05:38:45
In August 2026, the FDA approved zanidatamab (Ziihera) in combination with tislelizumab and chemotherapy for HER2-positive advanced gastroesophageal adenocarcinoma, achieving a median OS of 26.4 months. This article details the clinical data, indications, safety warnings, and dosing guidelines.
2026-08-24 07:36:03
Two neurokinin receptor antagonists—fezolinetant and elinzanetant—have been approved as non-hormonal therapies for menopausal vasomotor symptoms. Data from the 2026 NIRVANA trial further confirm elinzanetant's efficacy in improving menopause-related sleep disturbances.
2026-08-18 03:25:17
In August 2026, the FDA approved Tauklarify (florquinitau F-18 injection, MK-6240), a radioactive diagnostic agent for PET imaging of tau neurofibrillary tangles in adult patients with cognitive impairment being evaluated for Alzheimer's disease.
2026-08-17 07:50:41
Bristol Myers Squibb announced FDA approval of Zenbexus (iberdomide) in combination with the ZDd regimen for adults with multiple myeloma who have received at least one prior line of therapy — the first approved CELMoD therapy.
2026-08-10 06:59:18
On August 6, 2026, Moderna’s mRNA seasonal influenza vaccine mFLUSIVA became the first mRNA flu vaccine approved by the U.S. FDA for adults aged 50 and older, ushering in a new era of mRNA-based influenza prevention.
2026-08-07 06:44:53
On August 5, 2026, the U.S. FDA approved Takeda's oral tablet Orzeyful (oveporexton) for adults with Narcolepsy Type 1 (NT1). As the first-in-class selective OX2 receptor agonist targeting the orexin pathway, Orzeyful moves beyond symptomatic relief to address the underlying orexin deficiency, simultaneously improving excessive daytime sleepiness, cataplexy, and disrupted nighttime sleep.
