FDA Archives - Page 72 of 220

2 minute read

May 9, 9:16 AM

Cue Health ("Cue") (NASDAQ:HLTH), a healthcare technology company, today announced that it has made a De Novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue RSV

HLTH

1 minute read

Zoetis’ Osteoarthritis Med for Dogs Set to Deliver Significant Advantages In 2024, Analyst Says

By Vandana Singh

May 8, 2:47 PM

Friday, the FDA approved Zoetis Inc's (NYSE: ZTS) Librela (bedinvetmab) for the control of pain associated with

ZTS

1 minute read

Eyenovia Shares Dip Despite FDA Approving Its First Product

By Vandana Singh

May 8, 2:39 PM

The FDA approved Eyenovia Inc's (NASDAQ: EYEN) Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term

EYEN

1 minute read

FDA Raises Concerns Regarding Perrigo’s OTC Birth Control Pill, Casts Doubts Over Real-World Use

By Vandana Singh

May 8, 12:47 PM

The FDA's Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) will be meeting this week to review Perrigo Company plc's (NYSE: PRGO) Opill daily oral contraceptive for

PRGO

1 minute read

FDA Lifts Clinical Hold From Immuron’s New Campylobacter ETEC Therapeutic Study

By Vandana Singh

May 8, 11:11 AM

Immuron Limited (NASDAQ: IMRN) has announced that the U.S.

IMRN

1 minute read

Why Immuron Stock Is Soaring Today

By Adam Eckert

May 8, 9:44 AM

Immuron Ltd (NASDAQ: IMRN) shares are trading higher Monday after the company announced the FDA removed the clinical hold on its new C

IMRN

2 minute read

ProMIS Neurosciences Announces FDA Clearance Of Investigational New Drug Application For PMN310 In Alzheimer’s Disease

By Happy Mohamed

May 8, 9:04 AM

In preclinical studies, PMN310 demonstrated the ability to selectively target and protect against pathogenic Aβ oligomers The IND clearance of PMN310 in

PMN

2 minute read

Glaukos Announces FDA Acceptance Of NDA Submission For iDose TR

By Happy Mohamed

May 5, 4:09 PM

PDUFA Date Set for December 22, 2023 Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal

GKOS

2 minute read

Arbutus Biopharma Q1 Exceeds Consensus View; Cuts Cash Burn Guidance

By Lekha Gupta

May 4, 3:33 PM

Arbutus Biopharma Corp (NASDAQ:ABUS) reported Q1 2023 revenues of $6.7 million, beating the consensus of $6.02 million. Revenues declined from…

ABUS

4 minute read

SELLAS Announces Topline Data From GFH009 Phase 1 Dose-Escalation Trial In Acute Myeloid Leukemia Cohort Supporting Advancement To Phase 2 Clinical Study

By Happy Mohamed

May 4, 8:38 AM

- 72 Acute Myeloid Leukemia and Lymphoma High-Risk Advanced Patients Enrolled: 94% Alive at Last Assessment Indicating Favorable Survival Benefit - - Long-Term Complete Remission and Significant Bone Marrow

SLS