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FDA Grants ImmunityBio Approval to Supply Recombinant BCG (rBCG) Amid TICE BCG Shortage

Feb 20, 2025
ImmunityBio, Inc. announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a…
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Rznomics Inc. Liver Cancer Drug Receives Fast Track Designation

Feb 19, 2025
Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular…
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FDA Accepts Dupixent sBLA for Bullous Pemphigoid Treatment under Priority Review

Feb 19, 2025
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous…
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FDA Accepts Gilead’s NDA for Twice-Yearly Lenacapavir for HIV Prevention

Feb 19, 2025
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly…
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Biogen and Stoke Therapeutics Partner to Develop Zorevunersen for Dravet Syndrome Treatment

Feb 19, 2025
Biogen Inc. and Stoke Therapeutics, Inc. announced a collaboration for the development and commercialization of zorevunersen, a potential first-in-class disease modifying medicine in…
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FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for Sézary Syndrome

Feb 18, 2025
Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing…
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FDA Grants Full Approval of Deciphera’s ROMVIMZA for TGCT Treatment

Feb 18, 2025
Ono Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ROMVIMZA (vimseltinib), a kinase inhibitor, for adult patients with symptomatic…
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FDA Approves GSK’s Penmenvy 5-in-1 Meningococcal Vaccine for MenABCWY Protection

Feb 17, 2025
GSK plc announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. …
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QIAGEN Expands Bioinformatics Leadership with New Data Center in Australia/APAC

Feb 14, 2025
QIAGEN announced the official opening of a new data center in Melbourne, Australia, designed to strengthen its global bioinformatics leadership position in this region of the world.…
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Newleos Therapeutics Raises $93.5M in Oversubscribed Series A to Advance Neuropsychiatric Disorder…

Feb 14, 2025
Newleos Therapeutics, Inc., a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, announced the closing of an oversubscribed…
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