Galapagos Assumes Responsibility Of Late-Stage Filgotinib Trial In Crohn’s Disease
Galapagos NV (NASDAQ:GLPG) has randomized the last patient into the DIVERSITY Phase 3 study of filgotinib in the induction and maintenance…
Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
Following a mixed month for regulatory approvals, biotech investors now turn toward a month of plenty as far as Food and Drug Administration decisions are concerned.
Gilead’s Kite Files US Application To Expand Use Of Yescarta In Second-Line Setting
Kite Pharma, a Gilead Science Inc Company (NASDAQ:GILD), has submitted a supplemental marketing application to the FDA for Yescarta (axicabtagene ciloleucel). The…
The Daily Biotech Pulse: Merck Rallies On Antiviral Pill Data, Gilead Files For Yescarta Label Expansion, Exscientia IPO
Here's a roundup of top developments in the biotech space over the last 24 hours.
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Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Sept. 30)
Gilead Says Kite Submits Supplemental Biologics License Application To FDA For Earlier Use Of Yescarta In Large B-cell Lymphoma
Kite, a Gilead Company (NASDAQ:GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta® (axicabtagene
GSK, Pfizer Backed Long-Acting HIV Med Under FDA Priority Review As Preventative Option
The FDA has accepted and granted Priority Review to ViiV Healthcare’s marketing application seeking approval for injectable cabotegravir long-acting for pre-exposure prophylaxis…
Gilead Scores Fifth Approval For Trodelvy In Triple-Negative Breast Cancer, This Time In Canada
Health Canada has approved Gilead Sciences Inc’s (NASDAQ:GILD) Trodelvy (sacituzumab govitecan-hziy) for previously treated breast cancer patients. The approval comes…
Pfizer Begins Late-Stage Study To Test Effectiveness Of Oral Drug Against COVID-19 In Those Exposed To The Virus
Pfizer Inc (NYSE: PFE) says it has begun late-stage testing for an oral drug that can be taken by persons who are exposed to the virus that causes COVID-19.
Gilead Marks Fifth Approval For Trodelvy In Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative With Health Canada Authorization
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that Health Canada has approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic