FDA Archives - Page 48 of 220

2 minute read

Mesoblast Shares Tumble As FDA Strikes Out Cell Therapy Application For Children Again, Requires Additional Trial

August 4, 9:24 AM

The FDA issued a complete response letter to Mesoblast Limited's (NASDAQ: MESO) resubmission for remestemcel-L for pediatric steroid-refractory acute graft

MESO

1 minute read

Oncternal Therapeutics Receives FDA Study May Proceed Letter For ONCT-534, Its Novel Dual-Action Androgen Receptor Inhibitor, For The Treatment Of Patients With Advanced Prostate Cancer

By Benzinga Newsdesk

August 3, 5:22 PM

Oncternal Therapeutics, Inc. (NASDAQ:ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the receipt of a Study May Proceed letter from the U.S. Food

ONCT

1 minute read

Outset Medical Stock Tumbles After Shipment Pause Of TabloCart – Here’s Why

By Vandana Singh

August 3, 1:39 PM

In its Q2 earnings release, Outset Medical Inc (NASDAQ: OM) announced it has paused the shipment of TabloCart with Prefiltration, an accessory for the Tablo System, pending the FDA's clearance of a 510(k) the company plans to

1 minute read

Why Is Regeneron Pharmaceuticals Moving Higher Today?

By Vandana Singh

August 3, 10:35 AM

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) earned second-quarter adjusted EPS of $10.24, up 5% Y/Y, beating the $9.92 Stre

AMGN

3 minute read

Eyenovia Announces First Commercial Sale Of Mydcombi

By Happy Mohamed

August 3, 8:23 AM

Represents the first FDA approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation Validates Eyenovia's proprietary Optejet® dispensing

EYEN

2 minute read

180 Life Sciences Provides Update On Regulatory Approval Process In The UK And U.S. For Dupuytren’s Disease Treatment; Continues Consultations With The UK MHRA And Initiates A Type C Meeting Request With the U.S. FDA

By Happy Mohamed

August 3, 8:22 AM

180 Life Sciences Corp. (NASDAQ:ATNF) ("180 Life Sciences" or the "Company"), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in

ATNF

2 minute read

THC-Based Alzheimer’s Trial In Puerto Rico: IGC Pharma Targets Underrepresented Hispanic Communities

By Nicolas Jose Rodriguez

August 2, 5:05 PM

IGC Pharma, Inc.

CNBS

2 minute read

BeautyHealth’s SkinStylus Receives New FDA Clearance For Facial Acne Scarring

By Happy Mohamed

August 2, 8:14 AM

Now the only microneedling device FDA-cleared for use on both the face and abdomen Milestone achievement in just five months since BeautyHealth's acquisition of the brand The Beauty Health Company (NASDAQ:SKIN),

SKIN

3 minute read

Rescheduling Cannabis: What Are The Implications For MSOs, Tax Rule 280E, FDA And Pharma?

By Nicolas Jose Rodriguez

August 1, 1:26 PM

The potential of rescheduling and removing Tax Rule 280E could boost profits for U.S. businesses. However, Zuanic and Associates' latest report reveals complexities and overlooked consequences.

CNBS

1 minute read

GSK’s Jemperli Plus Chemo Combo Scores FDA Approval As First New Frontline Treatment For Certain Type Of Endometrial Cancer

By Vandana Singh

August 1, 9:36 AM

The FDA approved GSK plc's (NYSE: GSK) Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined b

GSK