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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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NIKTIMVO (Axatilimab) Approved in Australia as First-in-Class Chronic Graft-Versus-Host Disease Treatment
Australia's TGA approves NIKTIMVO (axatilimab), a breakthrough first-in-class therapy for chronic graft-versus-host disease under priority review.
IPEC Annual Meeting 2026: No Pharma News Today
No official confirmation or breaking pharmaceutical news from the IPEC Annual Meeting 2026 is currently available in public sources. Pharmaceutical professionals should verify event status directly with the International Pharmaceutical Excipients Council.
Excipient World Conference 2026: No Pharma Breaking News
The Excipient World Conference 2026 has not generated breaking pharmaceutical news as of May 4, 2026. However, emerging market trends in lipid-based vitamin C, natural oil excipients, and biodegradable packaging solutions provide strategic insights for pharma excipient professionals.
APHL 2026 Annual Meeting Opens: Public Health Lab Focus
The APHL 2026 Annual Meeting commenced today in Baltimore, MD, bringing together public health laboratory leaders, scientists, and partners to discuss critical issues and advancements in the field. The conference, running from May 4–7, will address key trends in laboratory science and public health.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
FDA Approves First Non-Antipsychotic for Dementia Agitation
The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in Pivotal Aortic Valve Trial
Edwards Lifesciences announces 10-year COMMENCE trial results demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
BioMarin VOXZOGO Shows Long-Term Benefits for Achondroplasia in New Clinical Data at PES 2026
BioMarin presents new VOXZOGO data showing long-term benefits on arm span, bone health and growth in children with achondroplasia at PES 2026 meeting.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis, Polycythemia Vera Treatment
Incyte receives FDA approval for Jakafi XR (ruxolitinib) extended-release tablets, offering improved dosing convenience for rare blood cancer patients.
Plozasiran TGA Approval: REDEMPLO® Now Available in Australia for FCS
Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing treatment options for patients with Familial Chylomicronemia Syndrome (FCS). This approval expands global access to the novel therapy for this rare genetic disorder.
Neurocrine Biosciences CRENESSITY Shows Sustained Benefits in Two-Year Pediatric CAH Study
CRENESSITY (crinecerfont) demonstrates durable hormone control and reduced glucocorticoid exposure in pediatric congenital adrenal hyperplasia patients.
Cairn Surgical's Breast Cancer Locator System Meets Primary Endpoint in Pivotal Trial, Reduces Positive Margin Rates
Cairn Surgical announces positive pivotal trial results for its Breast Cancer Locator System, showing reduced positive margin rates compared to conventional wire localization.
Restore Vision Reports Positive Safety Data for RV-001 Gene Therapy in Retinitis Pigmentosa Trial
Restore Vision's RV-001 optogenetic gene therapy shows no dose-limiting toxicities in Phase I/II trial for advanced retinitis pigmentosa patients at 168 days.
ARCHIMED Acquires Esperion Therapeutics in Strategic Cardiometabolic Deal
Healthcare investment firm ARCHIMED announces definitive agreement to acquire Esperion Therapeutics, maker of cholesterol drugs NEXLETOL and NEXLIZET.
Oculis to Present DME Research and Pipeline Updates at ARVO 2026 Annual Meeting
Oculis will present findings from DME AWARE Delphi Study highlighting unmet needs in diabetic macular edema treatment at ARVO 2026 meeting.
Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity
IMCIVREE becomes first therapy approved in both US and Europe for acquired hypothalamic obesity, targeting adults and children 4+ with hypothalamic injury.
Atara Biotherapeutics Receives FDA Complete Response Letter for EBVALLO Cancer Treatment, Faces Securities Class Action
Atara Biotherapeutics' EBVALLO cancer therapy receives FDA Complete Response Letter, delaying approval as company faces securities class action lawsuit deadline May 22, 2026.
Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
Vanda Pharmaceuticals' NEREUS (tradipitant) is now commercially available in the US, marking the first new prescription motion sickness treatment in over 40 years.
Novo Nordisk's Oral Ozempic Becomes First FDA-Approved Pill GLP-1 for Type 2 Diabetes with Cardiovascular Protection
Novo Nordisk's oral Ozempic pill receives FDA approval as the first oral GLP-1 medication for type 2 diabetes with cardiovascular risk reduction benefits.
ZETA SURGICAL Receives FDA 510(k) Clearance for Brain Surgery Navigation System
ZETA SURGICAL's Zeta Navigation System receives FDA 510(k) clearance for brain tumor biopsies, hydrocephalus treatment, and trigeminal neuralgia procedures.