Biotech Archives - Page 698 of 733

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Passage Bio Commences Initial-Stage Brain Disorder Study

August 11, 9:57 AM

Passage Bio (NASDAQ: PASG) has dosed the first patient in the global Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for the treatment of patients with frontotemporal dementia (FTD) with granulin (GRN) mutations.

PASG

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Deciphera’s Cancer Drug Tops Pfizer’s Sutent On Safety Front In Gastrointestinal Cancer

By Vandana Singh

August 11, 9:45 AM

The Journal of Clinical Oncology has published results from Deciphera Pharmaceuticals Inc (NASDAQ:DCPH) INTRIGUE Phase 3 study of Qinlock (ripretinib) for advanced…

DCPH

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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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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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Bausch Health to Appeal XIFAXAN Patent Decision to U.S. Court of Appeals for the Federal Circuit, Says Expects Decision To Issue Within 12-18 Months

By Michael Horton

August 10, 6:01 PM

Bausch Health Companies Inc. (TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, consistent with the company's July 28, 2022, press release, the U.S. District Court

BHC

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This Analyst Says Zentalis’ Increased Focus On WEE1 Program Is ‘Prudent’, Slashes Price Target By 37%

By Vandana Singh

August 10, 4:39 PM

Zentalis Pharmaceuticals Inc (NASDAQ:ZNTL) decided to discontinue the development of oral SERD asset ZN-c5 and EGFR inhibitor ZN-e4 following the completion…

AZN

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Rani Therapeutics Announces Topline Results from Phase 1 Study of RT-102 in Osteoporosis

By Michael Horton

August 10, 4:35 PM

Rani Therapeutics Holdings, Inc. ("Rani Therapeutics" or "Rani") (NASDAQ:RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive

RANI

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ReShape Lifesciences Shares Soar As FDA Announced Clearance To GIBI HD Calibration Tubes In Weight Loss Procedures

By Ragothaman Srinivasan

August 10, 12:42 PM

The U.S. Food and Drug Administration (FDA) has announced 510(k) clearance to ReShape Lifesciences’ (NASDAQ: RSLS) Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for use in gastric and bariatric surgical procedures.

RSLS

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Lexaria Gets FDA’s Positive Feedback On Pre-Clinical Trial Of Hypertension Candidate

By Ragothaman Srinivasan

August 10, 11:36 AM

Lexaria Bioscience Corp. (NASDAQ: LEXX) announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for the treatment of hypertension.

LEXX