Sanofi earns orphan drug designation from USFDA for multiple myeloma drug Ruchika Sharma30 July 2025 1:30 PM ISTParis: Sanofi has received orphan drug designation from the US Food and Drug Administration (FDA) for SAR446523, an IgG1-based...
Sanofi Sarclisa approved in EU for transplant-eligible newly diagnosed multiple myeloma Ruchika Sharma27 July 2025 2:00 PM ISTParis: Sanofi has announced that the European Commission has approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone...
GSK Blenrep combos approved in EU for treatment of relapsed/refractory multiple myeloma Ruchika Sharma27 July 2025 11:00 AM ISTLondon: GSK plc has received approval for Blenrep in the European Union (EU) for the treatment of adults with relapsed or refractory...
CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial Parthika Patel25 July 2025 4:38 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has not granted...
USFDA extends review period for GSK Blenrep in relapsed/refractory multiple myeloma Ruchika Sharma24 July 2025 1:30 PM ISTLondon: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics License Application...
JnJ Darzalex gets European Commission nod for high-risk smouldering multiple myeloma Ruchika Sharma24 July 2025 12:15 PM ISTBeerse: Janssen-Cilag International NV, a Johnson & Johnson company, has received approval from the European Commission (EC) for a new...
GSK fails to gain FDA advisers backing for cancer therapy Ruchika Sharma20 July 2025 11:30 AM ISTGSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk...
Ichnos Glenmark Innovation, AbbVie ink pact for investigational cancer drug Ruchika Sharma11 July 2025 2:54 PM ISTNew York: AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI), have announced an...
Alembic Pharma bags USFDA nod for cancer injection Doxorubicin Hydrochloride Liposome Ruchika Sharma1 July 2025 11:38 AM ISTVadodara: Pharmaceutical firm, Alembic Pharmaceuticals Limited, has announced that the company has received final approval from the US...
USFDA approves label updates for Bristol Myers Squibb 2 CAR T cell therapies Ruchika Sharma29 Jun 2025 12:30 PM ISTPrinceton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T...
USFDA lifts Risk Evaluation and Mitigation Strategies for CAR T cell therapies Ruchika Sharma28 Jun 2025 12:59 PM ISTThe U.S. Food and Drug Administration (USFDA) has announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently...
Sanofi Sarclisa recommended for EU approval by CHMP for transplant-eligible newly diagnosed multiple myeloma Ruchika Sharma23 Jun 2025 11:30 AM ISTParis: Sanofi has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive...
