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Tempus Wins FDA Approval for xT CDx, Expanding Solid Tumor Testing Portfolio
Tempus has received US FDA approval for its tumor-only xT CDx, becoming the first laboratory with companion diagnostic approval for both tumor-only and tumor-normal genomic profiling.
Regulation | 30/05/2026 | By News Bureau | 200
US FDA Approves DECNUPAZ for Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
AbbVie has received US FDA approval for DECNUPAZ to treat adults with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), marking the first and only outpatient-initiated ADC for BPDCN and AbbVie’s first approved Antibody Drug Conjugate (ADC) for hematologic malignancies.
Regulation | 30/05/2026 | By News Bureau
US FDA Grants Priority Review to Zydus Therapeutics' Saroglitazar for Primary Biliary Cholangitis
Zydus Therapeutics has received US FDA Priority Review (PR) for its New Drug Application (NDA) for saroglitazar in the treatment of Primary Biliary Cholangitis (PBC), supported by phase 3 EPICS-III trial results demonstrating significant biochemical response, with detailed data to be presented at the EASL Congress 2026.
Regulation | 29/05/2026 | By News Bureau | 128
ReST Therapeutics Receives US FDA IND Clearance for RST-101 in Early PTSD Treatment
ReST Therapeutics has received US FDA acceptance of its Investigational New Drug (IND) application for RST-101, enabling the initiation of a first-in-human clinical trial evaluating a novel early intervention approach for the treatment of post-traumatic stress disorder.
Regulation | 29/05/2026 | By News Bureau
IMFINZI from AstraZeneca has received US approval in combination with BCG for BCG-naïve, high-risk non-muscle-invasive bladder cancer, supported by Phase III POTOMAC trial data showing a 32 percent reduction in the risk of disease recurrence, progression, or death after one year of IMFINZI added to BCG vs. BCG alone.
Regulation | 29/05/2026 | By News Bureau | 100
Caliway Biopharmaceuticals secures US FDA IND clearance for CBL-0302, a global phase 3 clinical trial evaluating CBL-514 for non-surgical abdominal fat reduction.
Regulation | 28/05/2026 | By News Bureau | 143
Lupin Receives US FDA EIR for Ankleshwar Manufacturing Facility
Lupin has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Ankleshwar facility following the successful closure of a product-specific pre-approval inspection conducted in March 2026.
Regulation | 28/05/2026 | By News Bureau | 167
Solu Therapeutics Receives FDA Fast Track Status for STX-0712 in CMML Treatment
Solu Therapeutics receives US Food and Drug Administration (FDA) Fast Track designation for STX-0712 to treat chronic myelomonocytic leukemia (CMML), supporting accelerated development for patients with relapsed or treatment-resistant disease and limited therapeutic options.
Regulation | 28/05/2026 | By News Bureau
Gilead Sciences Wins FDA Accelerated Approval for First HDV Treatment Hepcludex
Gilead Sciences receives Food and Drug Administration (FDA) accelerated approval for Hepcludex, the first and only approved treatment for chronic Hepatitis Delta Virus (HDV), addressing a major unmet need in severe viral hepatitis care.
Regulation | 26/05/2026 | By News Bureau
Lupin Secures China Approval for Oseltamivir Phosphate Oral Suspension
Lupin receives approval in China for Oseltamivir Phosphate Oral Suspension 6 mg/mL, expanding access to influenza treatment, particularly for pediatric patients.
Regulation | 25/05/2026 | By News Bureau | 129
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