FDA Archives - Page 19 of 220

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Hoth Therapeutics Announces Expansion Of FDA Cleared First-In-Human Clinical Trial For Cancer Patients Of HT-001 At University Of Miami For The Treatment Of Skin Toxicities Associated With EGFRi Treatments

December 27, 9:22 AM

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced today that it has received approval from the University of Miami to enroll patients for its first in human clinical

HOTH

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Coherus BioSciences Stock Is Soaring After-Hours – Here’s Why

By Ryan Gustafson

December 26, 5:30 PM

Coherus BioSciences, Inc. (NASDAQ: CHRS) shares are trading higher in Tuesday's after-hours session following the company's announcement of the U.S.

CHRS

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Oncternal Therapeutics Reports Patient Death In Mid-Stage Blood Cancer Study Treated With Second Dose Level

By Vandana Singh

December 26, 12:41 PM

Oncternal Therapeutics Inc (NASDAQ: ONCT) updated the status of a recent study involving a treatment for relapsed or refractory aggressive B-cell lymphoma, including patients who have failed

ONCT

2 minute read

Scilex Announces Filing Of A New Drug Submission To Health Canada’s Pharmaceutical Drugs Directorate, Bureau Of Cardiology, Allergy And Neurological Sciences For The Approval Of ELYXYB For Acute Treatment Of Migraine With Or Without Aura In Canada

By Happy Mohamed

December 26, 12:01 PM

ELYXYB® is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1 The U.S. oral migraine drug market size is

SCLX

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Full Approval For Amgen’s Flagship Cancer Drug Lumakras Pushed For Around Four Years

By Vandana Singh

December 26, 11:45 AM

Amgen Inc (NASDAQ: AMGN) announced that the FDA has reviewed the company's supplemental New Drug Application, seeking full approval of the KRAS-blocking drug

AMGN

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Why Is Heart Disease-Focused Milestone Pharmaceuticals Stock Plummeting Today?

By Vandana Singh

December 26, 10:53 AM

Milestone Pharmaceuticals Inc (NASDAQ: MIST) announced Tuesday that the Company received a Refusal to File (RTF) letter from the FDA for the New Drug Application seeking approval for self-administered etripamil nasal spray for paroxysmal

MIST

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Amgen Provides Regulatory Update On Status Of Lumakras; FDA Has Issued New Postmarketing Requirement; LUMAKRAS Dosing Confirmed At 960 mg Once-Daily For Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval

By Happy Mohamed

December 26, 10:03 AM

FDA Has Issued New Postmarketing Requirement LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval THOUSAND OAKS, Calif., Dec. 26,

AMGN

2 minute read

Inspira Announces 95% Accuracy Results For HYLA Blood Sensor, Planning FDA Submission For Clearance In 2024

By Happy Mohamed

December 26, 9:46 AM

Inspira Technologies OXY BHN Ltd. (NASDAQ:IINN) (NASDAQ:IINNW) (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical

IINN

2 minute read

CVRx Receives FDA Approval For Expanded Labeling Of Barostim

By Happy Mohamed

December 26, 9:06 AM

CVRx, Inc. (NASDAQ:CVRX) ("CVRx"), a commercial-stage medical device company, announced today that the U.S. Food and Drug Administration (FDA) has approved revised Instructions For Use (IFU) for Barostim

CVRX

1 minute read

Why Is Blood Cancer Focused Senti Biosciences Stock Trading Higher Today?

By Vandana Singh

December 22, 11:12 AM

Senti Biosciences Inc (NASDAQ: SNTI) received FDA clearance for its Investigational New Drug (IND) application for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hemato

SNTI