Biotech Archives - Page 672 of 733

1 minute read

Vertex Pharma’s Flagship Cystic Fibrosis Drug Scores FDA Approval For Infants

September 2, 1:45 PM

The FDA has approved Vertex Pharmaceuticals Incorporated’s (NASDAQ:VRTX) Orkambi (lumacaftor/ivacaftor) for expanded use to include children with cystic fibrosis (CF) ages…

VRTX

1 minute read

Raymond James Initiates AnaptysBio With ~42% Upside, Despite Trial Setback

By Vandana Singh

September 2, 1:41 PM

Raymond James initiated coverage on AnaptysBio Inc (NASDAQ:ANAB) with an Outperform rating and a $35 price target. The analyst has a positive…

ANAB

1 minute read

Amylyx Pharmaceuticals Announces Posting Of Briefing Documents For Second FDA Advisory Committee Meeting On AMX0035

By Benzinga Newsdesk

September 2, 12:17 PM

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx or the "Company") today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central

AMLX

1 minute read

Johnson & Johnson To Settle New Hampshire Opioid Lawsuit With Payment Of $40.5M: Report

By Vandana Singh

September 2, 10:08 AM

Reuters reported that Johnson & Johnson (NYSE:JNJ) would pay $40.5 million to settle 2018 New Hampshire’s claims about the U.S. opioid epidemic,…

JNJ

1 minute read

PolyPid’s Lead Program Flunks Abdominal Surgery Study, Shares Tank

By Vandana Singh

September 2, 10:04 AM

PolyPid Ltd (NASDAQ: PYPD) shares lost almost 80% after announcing topline results from the SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery.

PYPD

1 minute read

BioNTech SE And Pfizer Confirm That They Have Filed Proceedings In Court Seeking That Two Of Curevac’s European Patents Are Not Infringed By Comirnaty And / Or Are Invalid

By Benzinga Newsdesk

September 2, 9:22 AM

- Reuters

BNTX

1 minute read

Immuneering Shares Climb After Pursuing FDA Nod For RAS Mutant Tumor Study

By Ragothaman Srinivasan

September 2, 9:09 AM

Immuneering (NASDAQ: IMRX) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its product candidate IMM-1-104 in development for the treatment of advanced RAS mutant solid tumors.

IMRX

3 minute read

PolyPid Announces Top-line Results Of Phase 3 SHIELD I Trial Of D-PLEX100 Did Not Achieve Its Primary Endpoint For The Prevention Of Surgical Site Infections In Abdominal Surgery

By Benzinga Newsdesk

September 2, 8:42 AM

SHIELD I Study did not Achieve its Primary Endpoint of Reduction in Surgical Site Infections and Mortality In an FDA Requested Pre-specified Subgroup Analysis in Subjects with Incision Lengths over 20 centimeters

PYPD

1 minute read

Microbot Medical Confirms GLP Pre-Clinical Trial Is On Track To Commence Later This Month

By Bill Haddad

September 2, 7:01 AM

HINGHAM, Mass., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT) announced, as part of the preparation for its anticipated U.S. Food and Drug Administration (FDA) and CE Mark submissions, that it

MBOT