FDA Archives - Page 84 of 220

2 minute read

Cocrystal Pharma To Present New Data From Its CC-42344 Phase 1 Influenza A Study At The 7th Annual ISIRV Antiviral Group Conference

April 18, 8:38 AM

Cocrystal Pharma, Inc. (NASDAQ:COCP) (Cocrystal or the Company) announces the acceptance of an oral presentation containing new data from the Company's CC-42344 Phase 1 influenza A study at the 7th Annual

COCP

1 minute read

ProSomnus Announces Publication Of Four Accepted Abstracts In The Journal Of Dental Sleep Medicine In Advance Of Annual Meeting

By Happy Mohamed

April 18, 8:23 AM

ProSomnus, Inc. ("the Company") (NASDAQ:OSA), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the publication of four abstracts in

OSA

2 minute read

Precision BioSciences Announces Late-Breaking Abstract Of Preclinical In Vivo Gene Editing Research Selected For Oral Presentation At The American Society Of Gene & Cell Therapy 26th Annual Meeting

By Happy Mohamed

April 18, 8:20 AM

- Presentation to Highlight Preclinical Development Progress of PBGENE-DMD Program for Potential Treatment of Duchenne Muscular Dystrophy Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage gene editing

DTIL

1 minute read

EXCLUSIVE: SAB Biotherapeutics Secures FDA Breakthrough Therapy Tag For Its Influenza Immunotherapy

By Vandana Singh

April 18, 8:00 AM

The FDA has granted Breakthrough Therapy Designation (BTD) to SAB Biotherapeutics Inc's (NASDAQ: SABS) SAB-176, an investigational therapy for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including antiviral resistant strains.

SABS

1 minute read

Gamida Cell Scores FDA Nod For Cord Blood-Based Cancer Therapy

By Vandana Singh

April 18, 6:48 AM

Gamida Cell Ltd’s (NASDAQ:GMDA) are jumping Tuesday premarket as the FDA approved Omisirge (omidubicel-onlv), an allogeneic cord blood-based cell therapy for…

GMDA

3 minute read

Reported Late Monday April 17, HUTCHMED Announces NDA Acceptance In China For Fruquintinib In Second-Line Gastric Cancer

By Happy Mohamed

April 18, 12:31 AM

HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that its New Drug Application ("NDA") for fruquintinib in combination with paclitaxel for the treatment of second-line

HCM

4 minute read

Reported Late Monday April 17, U.S. FDA Approves AbbVie’s QULIPTA For Adults With Chronic Migraine

By Happy Mohamed

April 18, 12:25 AM

QULIPTA® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic Expanded indication provides an additional treatment option for

ABBV

2 minute read

Adverum Biotechnologies Announces Upcoming Nonclinical Data Presentation Supporting Staggered Bilateral Administration Of Ixoberogene Soroparvovec At The 2023 ARVO Annual Meeting

By Happy Mohamed

April 17, 4:07 PM

Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will present an

ADVM

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GRAIL A Subsidiary Of Illumina And AstraZeneca Present New Data Demonstrating That Methylation Assay Detects Residual Hematologic Cancer After Treatment At AACR 2023

By Happy Mohamed

April 17, 4:06 PM

GRAIL's Methylation Assay Had 92% Cancer Detection Rate Across Six Hematologic Malignancies With 96% Accuracy in Determining the Hematologic Malignancy Subtype Findings Support Use of GRAIL's

AZN

8 minute read

First Report Of Dose Escalation Data Supports Best-In-Class Profile For Investigational Exarafenib As A Single Agent And In Combination With Binimetinib In BRAF-Altered Cancers And NRAS Mutant Melanoma

By Happy Mohamed

April 17, 2:32 PM

Exarafenib was well-tolerated at substantial monotherapy exposures; only 3% (n=2/60) of patients discontinued therapy due to treatment-related adverse events Breadth of responses observed across

KNTE