FDA Archives - Page 75 of 220

1 minute read

FDA Approves Teva/MedinCell’s Antipsychotic Injection For Adult Schizophrenia Patients

May 1, 8:38 AM

The FDA has approved Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) and MedinCell’s approved Uzedy (risperidone) extended-release injectable suspension for schizophrenia in adults. …

TEVA

2 minute read

Salarius Pharmaceuticals Reports No Adverse Safety Signals from Two Good Laboratory Practice Toxicology Studies With Its Targeted Protein Degrader SP-3164

By Benzinga Newsdesk

May 1, 8:34 AM

Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options,

SLRX

2 minute read

PainReform Announces Safety Data In First Part Of Phase 3 Clinical Trial Of PRF-110 In Patients Undergoing Bunionectomy Surgery

By Benzinga Newsdesk

May 1, 8:33 AM

PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive safety results in the

PRFX

1 minute read

FDA Advisory Committee Votes Favoring Restricted Use Of AstraZeneca/Merck’s Prostate Cancer Drug

By Vandana Singh

May 1, 6:20 AM

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against AstraZeneca Plc (NASDAQ:AZN) and Merck & Co Inc’s (NYSE:MRK) application seeking approval for…

AZN

2 minute read

Pliant Therapeutics Announces Long-Term Data From The INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast Was Well Tolerated At 320mg With Improvement Shown In FVC And Across Multiple Measures

By Benzinga Newsdesk

April 30, 3:51 PM

Bexotegrast was well tolerated up to 40 weeks of treatment with no drug-related serious adverse eventsCombination of bexotegrast with standard of care reduced FVC decline by 80% relative to standard of care

PLRX

4 minute read

Teva And MedinCell Announce FDA Approval Of UZEDY Extended-Release Injectable Suspension, A Long-Acting Subcutaneous Atypical Antipsychotic Injection, For The Treatment Of Schizophrenia In Adults

By Benzinga Newsdesk

April 29, 3:25 PM

This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1In a Phase 3 clinical trial, UZEDY demonstrated up to 80% reduction in

TEVA

1 minute read

FDA Warns Cybersecurity Vulnerability For Illumina Sequencers

By Vandana Singh

April 28, 7:52 AM

The FDA issued a letter noting that nearly the

ILMN

6 minute read

Avidity Biosciences Announces Topline Data From AOC 1001 Phase 1/2 MARINA Trial Demonstrating Functional Improvement, Disease Modification And Favorable Safety And Tolerability Profile In People Living With Myotonic Dystrophy Type 1

By Benzinga Newsdesk

April 27, 3:43 PM

Topline data presented at AAN annual meeting showed AOC 1001 achieved directional improvements in multiple functional endpoint assessments - myotonia (vHOT), measures of strength (total QMT) and mobility (10mWRT, Timed

RNA

2 minute read

FDA Casts Doubt on Merck/AstraZeneca’s Cancer Drug for Prostate Cancer Ahead of Adcomm Meeting

By Vandana Singh

April 27, 2:44 PM

The FDA's Oncologic Drugs Advisory Committee will be meeting tomorrow, Friday, 28 April, to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC).

AZN

7 minute read

Actinium Announces Pivotal Phase 3 SIERRA Trial Results Of Iomab-B Showcased To The European Transplant Community In Oral Presentation At The European Society For Blood And Marrow Transplantation Annual Meeting

By Happy Mohamed

April 27, 10:38 AM

- EBMT oral presentation builds awareness for Iomab-B and the SIERRA trial results with the European transplant community that performs twice as many transplants compared to the U.S. - Iomab-B

ATNM