US FDA Approves Olumiant for Pediatric Alopecia Areata
US FDA has approved Lilly’s Olumiant (baricitinib) for severe alopecia areata in patients aged 12 and older, based on the phase 3 BRAVE-AA-PEDS study.
Global Pharma | 28/09/2026 | By News Bureau
US FDA Approves Belzutifan-Lenvatinib for Advanced RCC
The US FDA has approved belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component.
Global Pharma | 28/09/2026 | By News Bureau
Merck's Remigromig Targets Wnt Pathway in Eye Disease
Merck’s remigromig meets the primary endpoint in the phase 2b/3 BRUNELLO study in adults with Diabetic Macular Edema (DME).
Global Pharma | 25/09/2026 | By News Bureau
Xenon Submits NDA for Azetukalner in Focal Seizures to US FDA
Xenon Pharmaceuticals has submitted an NDA to the US FDA for azetukalner in focal seizures, supported by data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials.
Global Pharma | 21/09/2026 | By News Bureau
Nuvation Bio Gets US FDA sNDA Approval for IBTROZI
Nuvation Bio has announced US FDA approval of sNDA for IBTROZI (taletrectinib), updating duration of response in TKI-naïve ROS1-positive NSCLC.
Global Pharma | 19/09/2026 | By News Bureau
Gilead Accelerates Access to Once-Yearly HIV Drug
Gilead speeds global access for once-yearly HIV drug lenacapavir, signing 6 royalty-free licensing deals for supplying in 120 high-incidence countries.
Global Pharma | 18/09/2026 | By News Bureau
Viatris Gets Approval for WAKIX in Japan
Viatris has got approval for WAKIX (Pitolisant), a first-in-class treatment for narcolepsy and Excessive Daytime Sleepiness (ESD) from sleep apnea, in Japan.
Global Pharma | 18/09/2026 | By News Bureau
Japan Approves Leqembi Pen, a Subcutaneous Formulation
Japan has approved Leqembi Pen, a once-weekly subcutaneous (SC) formulation for early Alzheimer's, offering at-home dosing alongside the intravenous (IV) option.
Global Pharma | 17/09/2026 | By News Bureau
US FDA Approves Telix's Brain Cancer Imaging Drug Pixclara
The US Food and Drug Administration (FDA) has approved Telix’s Pixclara, the first FET-PET imaging drug for glioma, helping differentiate recurrent or progressive brain cancer from treatment-related changes.
Global Pharma | 15/09/2026 | By News Bureau | 181
Sun Pharma Subsidiaries Reach Settlement in US Generic Drug Pricing Antitrust Litigation
Sun Pharma subsidiaries have reached a settlement with a plaintiff in a US generic drug pricing antitrust case for a confidential amount.
Global Pharma | 15/09/2026 | By News Bureau
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