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The Latest Breaking News from FDA

Moderna seeks emergency authorization for COVID-19 vaccine in young children

Moderna said last month its vaccine for kids generated a strong immune response.

Axios

Y-MAbs Therapeutics' CEO Exits, Expects FY22 Danyelza Sales of Up To $50M

Y-mAbs Therapeutics Inc's (NASDAQ:YMAB) CEO and Board Member, Claus Moller, has stepped down from his position effective immediately. Thomas Gad, the Company's Founder, Chairman & President, has assumed the interim CEO and Board Member role. In addition, Mr. Gad has stepped down as Chairman, and Jim Healy, current Board Member and Chair of…

Benzinga

Moderna asks FDA to authorize COVID-19 vaccine for kids under 6 - Roll Call

Moderna said Thursday that it asked the FDA for emergency use authorization of its COVID-19 vaccine in kids under age 6.

Roll Call

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World’s First AI-Ready Infrasound Stethoscope Gets FDA Approval

Sanolla’s VoqX can hear infrasound acoustic waves which, when analyzed by AI algorithms, supply lifesaving diagnostic insights.

Zenger

SQZ Biotechnologies Receives FDA Fast Track Designation for SQZ-PBMC-HPV for the Treatment of HPV16+ Tumors

SQZ Biotechnologies (NYSE: SQZ) received Fast Track Designation from he U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors. SQZ-PBMC-HPV-101 is currently being investigated in the Phase 1/2 clinical study.

Benzinga

McKinsey denies illegally hiding work for opioid-maker Purdue Pharma while advising FDA

Consulting firm was protecting client confidentiality, chief says, and wasn’t obliged to disclose work advising drug manufacturer

The Guardian - US

Insulet Highlights New Data For Omnipod 5 System For Type 1, Type 2 Diabetes

Insulet Corporation (NASDAQ:PODD) unveiled study results for the new Omnipod 5 automated insulin delivery system in type 1 and type 2 diabetes patients. Paired with DexCom Inc's (NASDAQ:DXCM) G6 continuous glucose monitoring (CGM) system, Omnipod 5 is the first tubeless, wearable, automated insulin delivery system. Related: FDA Approves Insulet's Omnipod Automated Insulin Delivery System Patients…

Benzinga

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Gamida Cell Posts Updated Omidubicel Data In Blood Cancer Patients

Gamida Cell Ltd (NASDAQ:GMDA) announced that updated infection data on omidubicel compared to umbilical cord blood transplantation (UCB) was shared at the Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings. The data from a sub-study of the Phase 3 trial of omidubicel showed early and enhanced recovery of various immune cells, including…

Benzinga

McKinsey exec faces questions on opioid, FDA consulting work

A top McKinsey executive is answering congressional questions about his company’s consulting work for the Food and Drug Administration even as it advised opioid drugmakers on boosting sales

The Independent UK

Why Molecular Partners Shares Are Getting Hammered

Molecular Partners AG (NASDAQ: MOLN) shares are trading lower by 36.52% at $8.38 after the company and its partner Novartis expects the FDA may require additional clinical data for the Emergency Use Application for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.

Benzinga

Novartis - BeiGene's Tislelizumab Aces Late-Stage Esophageal Cancer Trial

Novartis AG (NYSE:NVS) has announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC). Data showed that tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic…

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo (OTC:DSKYF) and AstraZeneca Plc's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months…

Benzinga

U.S. FDA Grants Orphan-Drug Designation for Allogene's ALLO-605 for multiple myeloma

Allogene Therapeutics, Inc. (Nasdaq: ALLO) received Orphan-drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its drug candidate ALLO-605 for the treatment of patients with multiple myeloma.

Benzinga

The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

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Benzinga

U.S. FDA accepts Fennec Pharma's New Drug Application (NDA) Resubmission for PEDMARK

Fennec Pharmaceuticals Inc. (NASDAQ: FENC) announced that the U.S.

Benzinga

Edwards Lifesciences Clocks 10% Top-Line Growth In Q1; Forecasts Lower Than Expected Q2 Sales

Edwards Lifesciences Corp (NYSE:EW) posted a Q1 adjusted EPS of $0.60, compared to $0.54 posted a year ago and beating the consensus of $0.57. Sales increased 10% to $1.34 billion (underlying 13%), beating the consensus of $1.31 billion. Transcatheter aortic valve replacement sales grew to $881 million, up 11%. Globally, the company's…

Benzinga

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

Benzinga

Molecular Partners, Novartis Note EUA For COVID-19 Therapy May Need Additional Data

Molecular Partners AG (NASDAQ:MOLN) has provided an update regarding the Emergency Use Application (EUA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19. The Company says that EUA, in review with the FDA, may require additional clinical data to be authorized. Vas Narasimhan also noted that the current omicron wave of SARS-Cov-2,…

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Axios

HIV PrEP is supposed to be covered, but often isn't

HIV prevention still comes with unexpected costs

Benzinga

71 Biggest Movers From Yesterday

Gainers

Benzinga

MMJ BioPharma Cultivation To Produce Quality Cannabis, Meeting DEA's Definition Of Chemical Reproducibility

MMJ BioPharma Cultivation, a cannabis company, received its DEA schedule 1 Analytical Lab Registration, which allows for the international importation of cannabis for research and development.

Salon

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

Salon

What's the difference between CBD & THC?

For starters, which one gets you high?

Benzinga

Pro-Patient Psychedelic Treatments Are Finally Moving Forward In A 'New Paradigm Shift'

Last week, Benzinga’s Psychedelics Capital Conference brought a premier gathering of the biggest publicly traded psychedelics companies in North America with forward-thinking investors to Miami, where the hottest topic seemed to revolve around LSD and derivative molecules.

Benzinga

Editas Medicine's EDIT-301 receives FDA Rare Pediatric Disease designation for Beta Thalassemia

The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia from leading genome editing company, Editas Medicine, Inc. (NASDAQ: EDIT).

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