Roche anticipates USFDA nod for SMA drug Risdiplam by early 2020 Medical Dialogues Bureau26 Nov 2019 9:28 AM ISTRoche, whose drug Risdiplam is seen as a rival for Biogen's Spinraza and Novartis's Zolgensma gene therapy, said the FDA is due to decide by May 24....
Mylan, TB Alliance to commercialize Pretomanid to treat TB Farhat Nasim23 April 2019 10:00 AM ISTTB Alliance began preclinical development of pretomanid in 2002, and it has since studied pretomanid in 20 clinical trials alone or in combination...
Upload application in SUGAM as per new Rules: CDSCO issues notice Meghna A Singhania13 April 2019 1:39 PM ISTNew Delhi: Through a recent notice, the Central Drugs Standard Control Organization (CDSCO) has informed that uploading of applications through SUGAM...
USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths Farhat Nasim21 March 2019 9:45 AM ISTThe clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid...
Philippine lawyers sue Sanofi over dengue vaccine Ruby Khatun Khatun9 Feb 2018 9:30 AM ISTMANILA: A Philippine government agency filed a lawsuit against French drugmaker Sanofi demanding compensation for the parents of a 10-year-old girl...
Did Sanofi, WHO ignore warning signals on dengue vaccine? Ruby Khatun Khatun15 Dec 2017 9:30 AM ISTCHICAGO/LONDON: When French drugmaker Sanofi published the results of clinical trials of children given its dengue vaccine two years ago, the overall...
More than 2,000 drugs now in cancer immunotherapy race Ruby Khatun Khatun9 Dec 2017 10:00 AM ISTLONDON: The race to develop new immunotherapy treatments against cancer has sparked an unprecedented explosion in the oncology drug pipeline, with...
Bill Gates makes 100 million dollars personal investment to fight Alzheimer Ruby Khatun Khatun15 Nov 2017 10:25 AM ISTLONDON: Billionaire Microsoft co-founder Bill Gates is to invest $50 million in the Dementia Discovery Fund, a venture capital fund that brings...
Zydus Cadila, Intas Pharma under CDSCO scanner for launching Unapproved drug Ruby Khatun Khatun10 Nov 2017 4:24 PM ISTNew Delhi: The Central Drug Standards Control Organization (CDSCO) has initiated an inquiry against the two domestic drug makers Zydus Cadila and...
FDA grants new indication for BRIVIACT for partial-onset seizures in patients 16 years and older with epilepsy. Ruby Khatun Khatun19 Sept 2017 9:24 AM ISTATLANTA and BRUSSELS: UCB announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for...