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 | 124
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 | 130
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 | 201
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 | 116
Accro Bioscience's AC-101 Enters NMPA Rare Disease Development Pilot Program
Accro Bioscience’s AC-101, a novel selective RIPK2 inhibitor, enters the NMPA CDE Caring Plan-Extension pilot program for rare disease drug development.
Global Pharma | 14/09/2026 | By News Bureau | 130
J&J's RYBREVANT Plus Chemotherapy Delivers Nearly 3-Year Survival in EGFR Exon 20 NSCLC
J&J’s RYBREVANT (amivantamab) plus chemotherapy delivers a median Overall Survival of 34.3 months in EGFR exon 20 insertion mutation-positive Non-Small Cell Lung Cancer (NSCLC).
Global Pharma | 14/09/2026 | By News Bureau | 113
WHO Prequalifies Multi-Dose Maternal RSV Vaccine Presentation
WHO has prequalified a multi-dose vial presentation of RSVpreF to support wider access to maternal RSV vaccination and help protect infants from severe respiratory illness.
Global Pharma | 11/09/2026 | By News Bureau | 105
Gilead Sciences Opens 182,000-Sq-Ft Research Centre at Foster City Headquarters
Gilead Sciences has opened a 182,000-square-foot research centre in Foster City, expanding its capabilities in oncology, inflammation and research data science.
Global Pharma | 10/09/2026 | By News Bureau | 111
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