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Articles

Ragothaman Srinivasan

Benzinga Staff Writer

August 09, 2022 6:29 PM
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ: RLMD) lead asset REL-1017 as a ...
August 09, 2022 4:56 PM
ClearPoint Neuro (NASDAQ: CLPT) announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to its Maestro Brain Model, intended ...
August 09, 2022 12:22 PM
NeuroOne Medical Technologies (NASDAQ: NMTC) has submitted a special 510(k) to the U.S. Food and Drug Administration (FDA) for its sEEG electrode to e ...
August 09, 2022 11:12 AM
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ: RLMD) lead asset REL-1017 as a ...
August 08, 2022 6:13 PM
Kodiak Sciences Inc. (NASDAQ: KOD) announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patien ...
August 08, 2022 5:31 PM
Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) initiated the Phase 3 VALOR study of its vaccine candidate VLA15 for Lyme disease patients. The VALOR ...
August 08, 2022 10:57 AM
TRACON Pharmaceuticals (NASDAQ: TCON) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for t ...
August 08, 2022 10:33 AM
Kodiak Sciences Inc. (NASDAQ: KOD) announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patient ...
August 04, 2022 6:07 PM
The European Commission (EC) has approved AstraZeneca (NASDAQ: AZN) and Merck’s (NYSE: MRK) LYNPARZA as monotherapy or in combination with endoc ...
August 04, 2022 5:01 PM
The U.S. Food and Drug Administration (FDA) announced clearance to Marker Therapeutics’ (NASDAQ: MRKR) Investigational New Drug (IND) appli ...
August 04, 2022 12:37 PM
Rain Therapeutics (NASDAQ: RAIN) has completed patient enrolment in its Phase 3 MANTRA trial of its lead asset, milademetan for well-differentiated / ...
August 04, 2022 12:03 PM
Astria Therapeutics (NASDAQ: ATXS) announced initiation of a Phase 1a clinical trial of STAR-0215 in healthy subjects. STAR-0215 is designed to provid ...
August 04, 2022 11:16 AM
The European Commission (EC) has approved AstraZeneca (NASDAQ: AZN) and Merck’s (NYSE: MRK) LYNPARZA as monotherapy or in combination with endoc ...
August 04, 2022 10:28 AM
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Qorvo’s (NASDAQ: QRVO) Qorvo Omnia SARS-CoV-2 ...
August 03, 2022 6:24 PM
The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ: MDWD) recently re-submitted Biologics License Applicat ...
August 03, 2022 5:18 PM
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Glaukos’ (NYSE: GKOS) iStent infinite Trabecular Micro-Bypass Syste ...
August 03, 2022 10:44 AM
Alnylam (NASDAQ: ALNY) announced positive results from the APOLLO-B Phase 3 study of Patisiran for the treatment of transthyretin-mediated (ATTR) amyl ...
August 03, 2022 10:22 AM
The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ: MDWD) recently re-submitted Biologics License Applicati ...
August 02, 2022 6:39 PM
Avalo Therapeutics (NASDAQ: AVTX) has dosed the first patient in the pivotal LADDER trial to assess the efficacy and safety of AVTX-803 in Subjects w ...
August 02, 2022 8:18 AM
Avalo Therapeutics (NASDAQ: AVTX) has dosed the first patient in the pivotal LADDER trial to assess the efficacy and safety of AVTX-803 in Subjects wi ...
August 01, 2022 6:41 PM
The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ: ELDN) Investigational New Drug (IND) application t ...
August 01, 2022 5:33 PM
The U.S. Food and Drug Administration (FDA) has announced clearance to Cellectis' (NASDAQ: CLLS) Investigational New Drug (IND) application to ini ...
August 01, 2022 5:03 PM
Aerie Pharmaceuticals (NASDAQ: AERI) has initiated patient dosing in the Phase 3 registrational COMET-3 study to evaluate AR-15512 ophthalmic solution ...
August 01, 2022 2:01 PM
Agenus (NASDAQ: AGEN) has dosed the first patient in the Phase 1 clinical study of AGEN1571 in advanced solid tumors. AGEN1571is a novel anti-ILT2 ant ...
August 01, 2022 12:01 PM
SCYNEXIS (NASDAQ: SCYX) announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of a supplemental New Drug Applica ...
August 01, 2022 11:43 AM
The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s (NASDAQ: GMDA) Biologics License Application (BLA) for omi ...
August 01, 2022 9:10 AM
The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’ (NASDAQ: KRYS) Investigational New Drug (IND) application to ...
August 01, 2022 8:29 AM
ALX Oncology Holdings (NASDAQ: ALXO) receives Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead asset Evorpacept in ...
August 01, 2022 8:05 AM
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Beam Therapeutics’ (NASDAQ: BEAM) Investigational New Drug (IND) appli ...
August 01, 2022 7:34 AM
The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ: ELDN) Investigational New Drug (IND) application to ...