Submit Full Adverse Event Data from Lenvatinib Phase IV Liver Cancer Trial: CDSCO Panel To Eisai Pharma Parthika Patel4 July 2025 1:00 PM ISTNew Delhi: In a recent regulatory review, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control...
USFDA nod to Leqembi IV maintenance dosing for treatment of early Alzheimer's Disease: Eisai, Biogen Ruchika Sharma27 Jan 2025 12:22 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental...
Eisai, nippon medac receive approval for Metoject subcutaneous injection pen (methotrexate) pen-type autoinjector in Japan Ruchika Sharma20 Feb 2024 4:00 PM ISTThe drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin).
USFDA approvals bounce back in 2023, sparking hopes of biotech recovery Ruchika Sharma3 Jan 2024 3:22 PM ISTThe U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an...
Merck-Eisai endometrial cancer therapy combo fails first-line treatment trial Ruchika Sharma9 Dec 2023 1:30 PM ISTRahway: Merck said on Friday a combination therapy being developed with partner Eisai failed a late-stage trial testing it as a first-line...
Biogen, Eisai get Japanese nod for Leqembi Intravenous Infusion for Alzheimer's Disease Ruchika Sharma25 Sept 2023 12:30 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI...
Setback: Merck-Eisai combination therapy fails in lung cancer studies Ruchika Sharma23 Sept 2023 2:21 PM ISTNew Jersy: Drugmakers Merck and Eisai said on Friday a combination of their cancer therapies did not prolong the lives of patients in two...
Merck, Eisai to shut down late stage study for combo cancer therapy Ruchika Sharma28 Aug 2023 12:31 PM ISTThe companies are testing the combination to treat a range of cancers, including those affecting the lungs and stomach.
USFDA grants traditional approval for Eisai Leqembi for Alzheimer's disease treatment Ruchika Sharma7 July 2023 1:30 PM ISTStockholm:BioArctic AB's (publ)partner Eisai has announced that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics...
Lupin unveils Rufinamide Oral Suspension for seizure disorder in US Ruchika Sharma23 Jun 2023 2:41 PM ISTMumbai: Global pharma major Lupin Limited today announced the launch of Rufinamide Oral Suspension, 40 mg/mL to market a generic equivalent of Banzel...
Eisai seeks marketing nod for Lecanemab for early Alzheimer's disease treatment in South Korea Ruchika Sharma11 Jun 2023 12:45 PM ISTLecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of...
USFDA advisory committee votes unanimously to confirm clinical benefit of Leqembi for Alzheimer's Disease Ruchika Sharma10 Jun 2023 1:30 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System...
