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  • Biotech
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FDA Approves GSK’s Whooping Cough Vaccine During Pregnancy For Prevention In Infants

By Vandana Singh
October 10, 6:01 AM
The FDA has approved GSK Plc’s (NYSE:GSK) Boostrix vaccine during the third trimester of pregnancy to prevent whooping cough in infants…

GSK

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FDA Says Issued Emergency Use Authorization To Abbott Molecular For Alinity m MPXV

By Michael Horton
October 7, 4:06 PM
-Reuters

ABT

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BrainStorm Presents New Biomarker Analyses From NurOwn’s Phase 3 ALS Trial At The ALS ONE Research Symposium

By Benzinga Newsdesk
October 7, 12:04 PM
NurOwn® drove biomarker responses, affecting pathways related to neurodegeneration, neuroinflammation, and neuroprotection, that were consistent in participants with both advanced ALS and less advanced disease,

BCLI

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Alnylam’s Lumasiran Scores Expanded FDA Approval For Ultra Rare Genetic Disease

By Vandana Singh
October 7, 10:56 AM
The FDA approved a label expansion for Alnylam Pharmaceuticals Inc’s (NASDAQ:ALNY) for Oxlumo (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now…

ALNY

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Amid FDA Dispute, Juul Labs Cancels Overseas Expansion Plans, Refinances Some Debt

By Vandana Singh
October 7, 6:49 AM
Juul Labs Inc's CEO, K.C. Crosthwaite, said the company is taking all necessary steps to keep it afloat. Altria Group Inc (NYSE: MO) has a minority stake in the company.

MO

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Late Thursday Reported, Merck And Ridgeback Biotherapeutics Provide Preliminary Analysis Update On New Clinical And Non-Clinical Studies Of LAGEVRIO; Primary Endpoint Was Not Met

By Benzinga Newsdesk
October 7, 12:33 AM
 

MRK

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Knight Therapeutics Late Thursday Announces Regulatory Submission For Tafasitamab In Brazil; Incyte Has Agreement To Exclusively Supply And Distribute For Co.

By Benzinga Newsdesk
October 7, 12:30 AM
MONTREAL, Oct.

INCY

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Lyell Immunopharma Announces FDA Clearance Of Its IND For LYL845, A TIL Product Candidate Enhanced With Its Novel Epigenetic Reprogramming Technology For Solid Tumors

By Benzinga Newsdesk
October 6, 4:07 PM
Autologous TIL therapy enhanced with Lyell's Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function   Phase 1 trial

LYEL

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Eli Lilly’s Obesity Drug, Tirzepatide, Fast Tracked In US; Rolling Submission To Start This Year

By Vandana Singh
October 6, 11:06 AM
The FDA has granted Fast Track designation for Eli Lilly And Co’s (NYSE: LLY) tirzepatide for adults with obesity or overweight with weight-related…

LLY

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  • FDA
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Desktop Health Receives FDA Clearance For SmileGuard Resin For Durable And Comfortable Orthodontic And Dental Appliances

By Benzinga Newsdesk
October 6, 8:43 AM
Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth guards in the office in as little as one hour, allowing same-day delivery Compared to other 3D printed

DM

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