FDA Archives - Page 6 of 220

2 minute read

NKGen Biotech Announces FDA Clearance Of IND Application For SNK01 NK Cell Therapy in Parkinson’s Disease

April 29, 8:08 AM

NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson's disease. The Company expects to initiate a Phase 1 clinical trial in

NKGN

2 minute read

FDA Green Lights Pfizer’s Gene Therapy For Rare Bleeding Disorder Hemophilia

By Vandana Singh

April 26, 2:30 PM

FDA approves Pfizer's Beqvez for adults with hemophilia B, offering a one-time treatment to produce FIX. Experience reduced bleeding frequency. Explore Pfizer's warranty program.

CSLLY

3 minute read

Biodexa Enters Into Exclusive License To eRapa, A Phase 3 Ready Asset For The Treatment Of Familial Adenomatous Polyposis; Worldwide Rights Come With $17M In Non-Dilutive Grant Funding For Pivotal Phase 3 Trial In FAP

By Benzinga Newsdesk

April 26, 8:34 AM

Biodexa Pharmaceuticals PLC("Biodexa" or the "Company")Biodexa Enters Into Exclusive License to eRapa™, a Phase 3 Ready Asset for theTreatment of Familial Adenomatous Polyposis (FAP)Worldwide rights come with $17

BDRX

2 minute read

Takeda Receives Positive CHMP Opinion For Fruquintinib In Previously Treated Metastatic Colorectal Cancer

By Benzinga Newsdesk

April 26, 8:32 AM

− If Approved in the European Union, Fruquintinib Will Be the First Novel Targeted Therapy for Metastatic Colorectal Cancer Regardless of Biomarker Status in Over a Decade− Positive Opinion Based on Results from a Phase

TAK

2 minute read

Compass Therapeutics Receives FDA Fast Track Designation For The Investigation Of CTX-009 In Combination With Paclitaxel For The Treatment Of Patients With Metastatic Or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated

By Benzinga Newsdesk

April 25, 8:01 AM

CTX-009, the Company's bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 studyTop-line data

CMPX

1 minute read

FDA Approves Novartis’ Lutathera As First Therapy For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

By Vandana Singh

April 23, 3:05 PM

Discover Novartis' FDA approval for Lutathera in pediatric patients with GEP-NETs, marking a pivotal milestone in treating this rare cancer. Explore its efficacy in combating SSTR+ tumors, backed by robust trial data.

NVS

1 minute read

Novartis Radioligand Therapy Lutathera FDA Approved First Medicine Specifically For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

By Benzinga Newsdesk

April 23, 2:15 PM

https://www.novartis.com/news/media-releases/novartis-radioligand-therapy-lutathera-fda-approved-first-medicine-specifically-pediatric-patients-gastroenteropancreatic-neuroendocrine-tumorsApproval based on NETTER-P trial

NVS

2 minute read

This Pharma Co. Kicks Off FDA Approval Process For CBD-Based Treatment Of Chronic Pain

By Jelena Martinovic

April 23, 10:24 AM

Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) announced on Monday that it has submitted its letter of application for a Pre-IND meeting with the U.S. Food and Drug Administration (FDA, for its Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain. With the move, the company initiated the regulatory process with the FDA for the approval of its prolonged CBD release technology for human use.

CSE:INNO

2 minute read

FDA Approves ImmunityBio’s Bladder Cancer Drug, Stock Rallies

By Vandana Singh

April 23, 9:54 AM

FDA approves ImmunityBio's Anktiva plus Bacillus Calmette-Guérin for BCG-unresponsive non-muscle invasive bladder cancer. Anktiva shows promising complete response rates and duration exceeding 24 months.

IBRX

1 minute read

FDA Rejects Approval Of Abeona Therapeutics’ Skin Disorder Treatment, Shares Sink

By Vandana Singh

April 23, 9:43 AM

Abeona Therapeutics' pz-cel gets the FDA's Complete Response Letter and Abeona's plans for fulfilling Chemistry Manufacturing and Controls requirements.

ABEO