FDA Archives - Page 56 of 220

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Vaxart Announces Preliminary Topline Data From Dose-Ranging Phase 2 Study Of Its Bivalent Norovirus Vaccine Candidate

July 6, 8:08 AM

Met all primary endpoints: Vaccine was well-tolerated with robust immunogenicity Continue to expect topline data from Phase 2 GI.1 challenge study in Q3 2023 SOUTH SAN FRANCISCO, Calif., July 06,

VXRT

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Merus N.V. Announces Zenocutuzumab Granted Second Breakthrough Therapy Designation By The U.S. Food & Drug Administration

By Happy Mohamed

July 5, 4:03 PM

– Zeno granted BTD for the treatment of NRG1+ non-small cell lung cancer UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 05, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology

MRUS

1 minute read

Abbott Scores FDA Nod For First Dual-Chamber Leadless Pacemaker To Treat Abnormal, Slow Heart Rhythms

By Vandana Singh

July 5, 12:34 PM

The FDA has approved Abbott Laboratories' (NYSE: ABT) AVEIR dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacing system to treat

ABT

3 minute read

GOP Official In NY Wants Permission To Ban Public Weed Use & More Cannabis Updates

By Nina Zdinjak

July 5, 9:53 AM

Lawmakers Praise FDA's Move To Issue Guidance On Psychedelics Research

JUSHF

2 minute read

Moderna Initiates Regulatory Application Process Seeking Approval For Its RSV Vaccine In Older Adults

By Vandana Singh

July 5, 9:17 AM

Moderna Inc (NASDAQ: MRNA) provided an update on regulatory submissions for the mRNA-1345 vaccine to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in

GSK

1 minute read

C4 Therapeutics Stock Is Surging: What’s Going On?

By Adam Eckert

July 5, 9:04 AM

C4 Therapeutics Inc (NASDAQ: CCCC) shares are rising Wednesday after the clinical-stage biopharmaceutical company announced the FDA cleared its investigational new drug (IND)

CCCC

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Daré Bioscience Provides Update On Activities To Support Commercial Launch Of XACIATO Vaginal Gel, 2%, FDA-Approved Treatment For Females 12 And Older With Bacterial Vaginosis, And Announced That Organon Will Pay Daré $1M In July 2023

By Happy Mohamed

July 5, 8:15 AM

Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today reaffirmed its commitment to the commercial launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal

DARE

2 minute read

Poseida Therapeutics Announces FDA Clearance Of Investigational New Drug Application For P-CD19CD20-ALLO1, An Allogeneic Dual CAR-T Cell Therapy For B-Cell Malignancies

By Happy Mohamed

July 5, 8:06 AM

Believed to be the first FDA IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20 SAN DIEGO, July 5, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage

PSTX