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Biotech

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Gilead’s Lenacapavir Scores European Approval For Pretreated HIV Patients After Manufacturing Delays

By Vandana Singh
August 22, 11:25 AM
The European Commission has approved Gilead Sciences Inc’s (NASDAQ:GILD) lenacapavir for adults with multi-drug resistant HIV infection.  The drug, branded as…

GILD

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Cue Biopharma Shares Decline Following Initial-Stage Metastatic Cancer Study Kicks-off

By Ragothaman Srinivasan
August 22, 11:17 AM
Cue Biopharma (NASDAQ: CUE) has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102 for the treatment of patients with Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.

CUE

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Minerva Seeks FDA Approval For Schizophrenia Candidate

By Ragothaman Srinivasan
August 22, 10:51 AM
Minerva Neurosciences (NASDAQ: NERV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone in the treatment of negative symptoms for patients with schizophrenia.

NERV

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Belite Bio Shares Gain On Initiation Of Late-Stage Retinal Disease Study

By Ragothaman Srinivasan
August 22, 10:23 AM
Belite Bio (NASDAQ: BLTE) has initiated enrollment for the U.S. Phase 3 clinical trial of its lead asset LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment.

BLTE

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UK Says Monkeypox Vaccines To Be Piloted In Smaller But ‘Equally Effective’ Doses

By Benzinga Newsdesk
August 22, 10:19 AM
-Reuters

AEMD

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Moderna to Supply 12M Doses of Omicron-Adapted COVID-19 Booster To Canada

By Vandana Singh
August 22, 10:04 AM
Moderna Inc (NASDAQ:MRNA) will supply 12 million doses of its COVID-19 shot adapted to target the Omicron variant of the coronavirus…

MRNA

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Salarius Pharmaceuticals Adds Two Mayo Clinic Sites To Its Ongoing Phase 1/2 Trial Of Seclidemstat As A Treatment For Ewing’s Sarcoma And FET-Rearranged Sarcomas

By Bill Haddad
August 22, 8:33 AM
Expands Trial to 17 U.S. Sites and 25 Locations  Initiation of All Anticipated U.S. Trial Sites Largely Completed HOUSTON, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX), a

SLRX

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Kronos Bio Announces First Patient Dosed In Phase 1b/2 Clinical Trial Of Lanraplenib In Combination With Gilteritinib In Acute Myeloid Leukemia

By Bill Haddad
August 22, 8:08 AM
Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in a Phase 1b/2 clinical trial of lanraplenib in

KRON

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Minerva Neurosciences Submits New Drug Application To FDA For Roluperidone For Treatment Of Negative Symptoms In Patients With Schizophrenia

By Bill Haddad
August 22, 8:01 AM
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has

NERV

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FDA Clears Insulet’s Omnipod 5 Automated Insulin Delivery System For Preschool Children

By Ragothaman Srinivasan
August 22, 7:39 AM
The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ: PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D).

PODD

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