Biotech Archives - Page 735 of 795

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

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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FDA
News

CDC Recommends Novavax Covid-19 Vaccine For Adolescents

By Benzinga Newsdesk

August 22, 11:09 AM

-Reuters

NVAX

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Anthony Fauci, Says Will Be Stepping Down From Positions Of Director Of NIAID And Chief Of The NIAID Laboratory Of Immunoregulation; Says Will Be Stepping Down From Position Of Chief Medical Advisor To President Joe Biden; Will Be Leaving In Dec.

By Benzinga Newsdesk

August 22, 11:03 AM

-Reuters

SPY

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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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FDA
News

Pfizer And Biontech Submit Application To FDA For Emergency Use Authorization Of Omicron Ba.4/ba.5-Adapted Bivalent Covid-19 Vaccine

By Benzinga Newsdesk

August 22, 10:37 AM

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older Companies have rapidly scaled

BNTX

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FDA
News

UK Says Under The Approach, Eligible People Will Be Offered 0.1ml Dose Of Smallpox Jynneos Vaccine, Instead Of 0.5ml Dose Typically Administered

By Benzinga Newsdesk

August 22, 10:29 AM

-Reuters

EWU

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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