FDA Archives - Page 7 of 220

2 minute read

Abeona Therapeutics Provides Regulatory Update On Pz-cel; CRL Did Not Identify Deficiencies Related To Clinical Efficacy Or Clinical Safety Data In BLA, And No New Clinical Studies Requested By FDA To Support Approval

Yesterday, 4:06 PM

Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies

ABEO

1 minute read

FDA Mandates “Boxed Warning” For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies

By Vandana Singh

April 19, 9:28 AM

Following an investigation announced in November last year, the FDA said on Thursday that it would now require boxed warnings—the highest safety-rel

BMY

2 minute read

FDA Classifies Boston Scientific’s Recall For Device To Stop Blood Flow As ‘Most Serious’

By Vandana Singh

April 18, 10:02 AM

Boston Scientific announces a Class I recall of Obsidio Embolic due to high-risk implications for lower GI bleeding embolization. Potential adverse effects include bowel ischemia, necessitating major surgery or resulting in prolonged hospitalization.

AXNX

2 minute read

Is Your Botox Real Or Fake? Counterfeit Boxes Circulate For Widely Used Antiwrinkle Treatment, CDC And FDA Investigate Harmful Reactions

By Vandana Singh

April 17, 2:42 PM

Be cautious of counterfeit Botox for cosmetic use. FDA warns of adverse reactions in multiple states. Symptoms include vision issues, difficulty breathing, and weakness. Ensure authenticity before use.

ABBV

2 minute read

Petros Pharmaceuticals Receives Response From FDA Following Recent Demonstration Of Technology Component In Pursuit Of OTC Status For STENDRA

By Benzinga Newsdesk

April 16, 9:18 AM

Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has received

PTPI

3 minute read

Jaguar Health Licenses FDA-Approved Oral Mucositis Product For U.S. Market, Initiating Commercial Footprint In Its Core Focus Area Of Cancer Supportive Care; Planning To Begin Commercial Launch In Q3 2024 For Gelclair

By Benzinga Newsdesk

April 16, 8:35 AM

Jaguar planning to begin commercial launch in Q3 2024 for Gelclair®, the company's third prescription productOral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology

JAGX

1 minute read

Why Is Penny Stock Soligenix Trading Higher On Monday?

By Vandana Singh

April 15, 1:55 PM

Soligenix secures FDA orphan drug designation for MarVax, a vaccine against Marburg marburgvirus (MARV). Benefits include market exclusivity, financial perks, and potential FDA fee waivers. MARV, akin to Ebola, lacks approved vaccines, highlighting urgent need."

SNGX

2 minute read

Abbott/Thoratec Corp. Recalls HeartMate II And HeartMate 3 Left Ventricular Assist System Due To Long-term Buildup Causing An Obstruction

By Benzinga Newsdesk

April 15, 11:26 AM

Please be aware, this recall is a correction, not a product removal.The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or

ABT

2 minute read

Why Is Neurology Focused-Neumora Therapeutics Shares Trading Lower On Monday?

By Vandana Singh

April 15, 10:17 AM

Neumora Therapeutics faces setbacks as FDA halts Phase 1 trial of NMRA-266 due to convulsion concerns in rabbits. Phase 1 study paused; company working with FDA for resolution.

NMRA

2 minute read

UroGen Announces FDA Acceptance Of IND Application For UGN-103, A Next Generation Mitomycin-Based Formulation For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

By Benzinga Newsdesk

April 15, 8:11 AM

UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process,

URGN