FDA Archives - Page 87 of 220

2 minute read

Inozyme Pharma To Present Recently Announced Preliminary Data From Ongoing Phase 1/2 Trial In ENPP1 Deficiency At The European Calcified Tissue Society Congress

April 14, 8:33 AM

Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today

INZY

5 minute read

Novocure Announces 27 Presentations, Including Real-World Evidence And Preclinical Research, At American Association For Cancer Research Annual Meeting 2023

By Happy Mohamed

April 14, 8:31 AM

Novocure (NASDAQ:NVCR) today announced 27 presentations on Tumor Treating Fields (TTFields) will be delivered at the American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 14 to 19 in

NVCR

1 minute read

Reported Late Thursday April 13, Alvotech Provides Regulatory Update On AVT02 Biologics License Application; FDA Issued Complete Response Letter For Alvotech’s Biologics License Application For AVT02, A High-Concentration Biosimilar Candidate For Humir…

By Happy Mohamed

April 14, 12:21 AM

Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has

ALVO

1 minute read

Reported Late Thursday April 13, AVITA Medical Announced That Its Automated Device, RECELL GO, Maintains FDA Breakthrough Device Designation For The Treatment Of Acute Wounds

By Happy Mohamed

April 14, 12:18 AM

AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH)))), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced

RCEL

1 minute read

Analysts Says Stat News Article Adds Uncertainty To Sarepta’s SRP-9001, But Offers Buying Opportunity Around The Weakness

By Vandana Singh

April 13, 12:35 PM

Earlier today, an article was published by Stat News noting that reviewers at the FDA were leaning toward…

SRPT

1 minute read

FDA Staff Had Inclination Towards Rejecting Sarepta Duchenne Gene Therapy

By Vandana Singh

April 13, 10:39 AM

Reviewers at the FDA were leaning toward rejecting Sarepta Therapeutics Inc's (NASDAQ: SRPT) closely watched gene therapy for Duchenne muscular dystrophy.

SRPT

1 minute read

EXCLUSIVE: FDA Grants Expedited Review Status To SAB Biotherapeutics’ Influenza Antibody

By Vandana Singh

April 13, 8:00 AM

The FDA has granted Fast Track designation for SAB Biotherapeutics' (NASDAQ: SABS) SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains.

RHHBF

2 minute read

Reported Late Wednesday April 12, Ardelyx Presents Data Further Supporting Efficacy And Safety Of XPHOZAH At National Kidney Foundation 2023 Spring Clinical Meetings

By Happy Mohamed

April 13, 12:57 AM

Three posters support the important role that XPHOZAH, a novel phosphate absorption inhibitor, could potentially play in the treatment of hyperphosphatemia XPHOZAH consistently lowered serum phosphate in

ARDX

3 minute read

EXCLUSIVE: Descheduling/Rescheduling Cannabis: Will It Be An Expeditious Path To 280E Relief? ‘This Is The One Moment To Do It’

By Joana Scopel

April 12, 7:27 PM

On Wednesday, a panel of experts at the Benzinga Cannabis Capital Conference discussed the issue of the IRS code 280E, which prohibits the marijuana industry from taking federal deductions.

CCHWF

1 minute read

FDA Issues Partial Clinical Hold On Merck Germany’s Multiple Sclerosis Study

By Vandana Singh

April 12, 10:12 AM

The FDA has placed a partial clinical hold on initiating new patients on Germany’s Merck KGaA’s (OTC:MKGAF) (OTC:MKKGY) evobrutinib and patients with…

MKGAF