FDA Archives - Page 198 of 220

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Palatin Reports Interim Analysis In Phase 3 Pivotal Study Of PL9643 In Patients With Dry Eye Disease

August 16, 7:33 AM

Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today

PTN

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FDA
News

AstraZeneca Announced Lynparza in Combination with Abiraterone Granted Priority Review in the US for Patients with Metastatic Castration-resistant Prostate Cancer

By Charles Gross

August 16, 4:52 AM

AstraZeneca's supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

AZN

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Inhibrx Announces European Medicines Agency Grants Orphan Drug Designation To INBRX-109 For The Treatment Of Chondrosarcoma

By Benzinga Newsdesk

August 15, 4:32 PM

Inhibrx, Inc. (NASDAQ:INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, today announced that the European Commission ("EC"), based on a positive opinion

INBX

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FDA Clears Organogenesis’ Next Generation PuraPly Surgical Solution

By Vandana Singh

August 15, 1:06 PM

Organogenesis Holdings Inc (NASDAQ:ORGO) has received the FDA 510k Clearance for PuraPly MZ, a brand extension to the PuraPly product portfolio. …

ORGO

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BrainStorm To File US Application For NurOwn In Amyotrophic Lateral Sclerosis

By Vandana Singh

August 15, 9:49 AM

BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI) announced its decision to submit a marketing application to the FDA seeking approval for NurOwn for…

BCLI

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Novavax Seeks FDA Emergency Use Nod For Its COVID-19 Vaccine Booster

By Vandana Singh

August 15, 9:28 AM

Novavax Inc (NASDAQ:NVAX) has submitted an application to the FDA for Emergency Use Authorization (EUA) for its protein-based COVID-19 vaccine as…

NVAX

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Gilead Sciences Announces Trodelvy Significantly Improves Overall Survival In Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients In The TROPiCS-02 Study

By Benzinga Newsdesk

August 15, 8:42 AM

Gilead Sciences, Inc. (NASDAQ:GILD) today announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3

GILD

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Amarin Corporation Announces Research Evaluating VASCEPA/VAZKEPA And Subgroups From The REDUCE-IT Landmark Outcomes Trial To Be Presented At The European Society Of Cardiology Congress

By Benzinga Newsdesk

August 15, 8:02 AM

Amarin Corporation plc (NASDAQ:AMRN) today announced new supported and/or funded research on the effects of VASCEPA®/VAZKEPA (icosapent ethyl) in specific patient subgroups at increased risk of a cardiovascular (CV)

AMRN