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4D Molecular Shares Fall After Filing For Fabry Disease Trial Amendment

By Vandana Singh
August 12, 11:20 AM
4D Molecular Therapeutics Inc (NASDAQ:FDMT) said that in June, the company filed a protocol amendment with the FDA for the ongoing…

FDMT

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Daiichi-AstraZeneca’s Flagship Cancer Drug Scores FDA Approval For Lung Cancer Harboring HER2 Mutation

By Vandana Singh
August 12, 9:37 AM
The FDA has approved Daiichi Sankyo (OTC:DSNKY) and AstraZeneca plc’s (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic non-small cell lung cancer (NSCLC)…

AZN

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Pfizer Announces Top-Line Results From Phase 3 Study Of 20-Valent Pneumococcal Conjugate Vaccine In Infants; Says 20vPnC Demonstrated Favorable Safety And Tolerability Profile

By Bill Haddad
August 12, 6:46 AM
Pivotal top-line data demonstrate a four-dose series of 20-valent pneumococcal conjugate vaccine candidate (20vPnC), if approved, would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in

PFE

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Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan
August 11, 6:07 PM
The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug…

ALXO

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Recalled Heartburn Pill Zantac Sets Fire To Glaxo and Sanofi Shares As Billions In Market Value Goes Up In Smoke

By Vandana Singh
August 11, 11:40 AM
Sanofi SA (NASDAQ: SNY), GSK Plc (NYSE: GSK), and Haleon Plc (NYSE: HLN) have lost a combined $40 billion in mar

GSK

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aTyr Pharma Shares Ascend As FDA Grants Fast Track Status To Lung Disease Candidate

By Ragothaman Srinivasan
August 11, 9:32 AM
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis, a major form of interstitial lung disease.

LIFE

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Bionano Genomics Announces First Publication Using OGM For Detection Of Repeat Expansions In CANVAS And Adult-Onset Ataxia

By Benzinga Newsdesk
August 11, 8:04 AM
ionano Genomics, Inc. (NASDAQ:BNGO) today announced the publication of the first study to evaluate the utility of optical genome mapping (OGM) in the analysis of repeat expansion disorders. Repeat expansion disorders are

BNGO

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Menarini Group’s Elacestrant Granted Priority Review By The U.S. FDA For Patients With ER+/HER2- Advanced Or Metastatic Breast Cancer

By Benzinga Newsdesk
August 11, 6:48 AM
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast

RDUS

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Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan
August 10, 6:23 PM
Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT) announced positive topline results from KarMMa-3, a Phase 3 study…

BBIO

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ReShape Lifesciences’ GIBI HD Calibration Tubes Scores FDA Approval For Tummy Tuck Procedures

By Vandana Singh
August 10, 2:35 PM
ReShape Lifesciences Inc (NASDAQ:RSLS) has received FDA 510(k) clearance for the disposable Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for…

RSLS

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