Questions Surround Vertex/CRISPR’s Sickle Cell Gene Therapy As FDA AdComm Meeting Approaches
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet next
FDA Gives Nod To Eli Lilly’s First Treatment For Type Of Inflammatory Bowel Disease, To Compete With JNJ, Pfizer, AbbVie
The FDA approved Eli Lilly And Co's
FDA Says On October 24, Issued Warning Letter To Abbott Laboratories On Oct. 24, For Product, Similac Probiotic Tri-blend; Has Not Approved Any Probiotic Product For Use As A Drug Or Biological Product In Infants Of Any Age
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-laboratories-669353-10242023
WARNING LETTER
Date: October 24, 2023
FDA Accepts ImmunityBio’s BLA Resubmission As Complete And Sets New PDUFA Date Of April 23, 2024
BLA for N-803 plus BCG in high-risk non-muscle-invasive bladder cancer (NMIBC) was resubmitted to the Agency on October 23, 2023A new PDUFA date of April 23, 2024 has been communicated by the AgencyImmunityBio, Inc.
Mustang Bio Announces FDA Acceptance Of IND Application For MB-109, A Novel Combination Of MB-101 And MB-108, For The Treatment Of Recurrent Glioblastoma And High-Grade Astrocytoma
MB‐101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) are separately well tolerated in patients with recurrent GBM in ongoing Phase 1 clinical trials; preclinical data support potential of
22nd Century Group Supports FDA Policy Advancements, Proposed Menthol Ban Now At OMB
22nd Century Group, Inc. (NASDAQ:XXII), a leading biotechnology company focused on utilizing advanced plant technologies to improve health and wellness with reduced nicotine tobacco, hemp/cannabis and hops, announced
Aytu BioPharma Announces Approval Of The Cotempla XR-ODT Manufacturing Site Transfer Prior Approval Supplement
U.S. Food & Drug Administration Approval of the Prior Approval Supplement (PAS) Enables Transfer of Cotempla Production to Contract ManufacturerUpon Completion of Manufacturing Transfer of Adzenys XR-ODT and Cotempla
PaxMedica Holds Important FDA Type-B Meeting To Review PAX-101 Pivotal Trial Data; Key Guidance Regarding NDA Filing Obtained
Key Guidance Regarding NDA Filing Obtained PaxMedica, Inc. (NASDAQ:PXMD), a clinical-stage biopharmaceutical company, announced the completion of a type-B meeting with the FDA. During the live meeting, the company
Akebia Receives FDA Acceptance Of Resubmission To NDA Of Vadadustat For The Treatment Of Anemia Due To Chronic Kidney Disease
March 27, 2024 Set as User Fee Goal DateAkebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food
FDA Accepts For Review AstraZeneca’s Supplemental Biologics License Application For Self-Administration Of FluMist Quadrivalent
AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the