FDA Archives - Page 31 of 220

2 minute read

Sana Biotechnology Announces FDA Clearance oOf Investigational New Drug Application For SC291, A Hypoimmune-Modified, CD19-Directed Allogeneic CAR T Therapy, For Patients With Lupus Nephritis, Extrarenal Lupus, And ANCA-Associated Vasculitis

Yesterday, 5:28 PM

Phase 1 trial to investigate multiple B-cell mediated autoimmune diseases First healthy donor-derived allogeneic CAR T cell therapy to announce IND clearanceExpect to disclose initial clinical data next yearSEATTLE,

SANA

2 minute read

Lyell Immunopharma Receives FDA Orphan Drug Designation For LYL845 For The Treatment Of Melanoma

By Benzinga Newsdesk

Yesterday, 5:22 PM

Lyell Immunopharma, Inc. (NASDAQ:LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, today announced that the U.S. Food and Drug

LYEL

3 minute read

Takeda’s ADZYNMA Approved By U.S. FDA As The First And Only Recombinant ADAMTS13 Enzyme Replacement Therapy For The Treatment Of Congenital Thrombotic Thrombocytopenic Purpura

By Benzinga Newsdesk

Yesterday, 3:56 PM

cTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic SymptomsTakeda Continues 70-plus Year Legacy of Driving Innovation for the Rare Hematology

TAK

4 minute read

U.S. FDA Accepts For Priority Review Bristol Myers Squibb’s Application For Breyanzi Fior Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma

By Benzinga Newsdesk

Yesterday, 10:14 AM

Application based on results from TRANSCEND CLL 004, the first pivotal multicenter trial to show clinical benefit with a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, in which

BMY

2 minute read

Owlet Achieves De Novo FDA-Clearance For Dream Sock, The First And Only Over-The-Counter, Medical Grade Pulse Oximeter Cleared For Infants

By Benzinga Newsdesk

Yesterday, 8:37 AM

Owlet, Inc. (NYSE:OWLT) (the "Company" or "Owlet"), the pioneer of smart infant monitoring, announces De Novo clearance from the U.S. Food and Drug Administration ("FDA") of Dream Sock, the first and only

OWLT

3 minute read

Atara Biotherapeutics Announces Primary Analysis Data From Phase 2 EMBOLD Clinical Trial Of ATA188 In Non-Active Progressive Multiple Sclerosis; Primary Endpoint Of Confirmed Disability Improvement At 12 Months Not Achieved

By Benzinga Newsdesk

November 8, 7:04 PM

Primary Endpoint of Confirmed Disability Improvement at 12 Months Not AchievedCompany to Further Analyze Data and Evaluate Strategic Options for ATA188 Program with Focusing of Resources and Planned Expense Reductions

ATRA

1 minute read

Weight Loss Drug Competition – FDA Approves Expanded Use Of Eli Lilly’s Blockbuster Tirzepatide For Weight Loss, Undercutting Novo Nordisk’s Price

By Vandana Singh

November 8, 3:04 PM

The FDA has approved

LLY

4 minute read

FDA: Safety & Effectiveness Of Coadministration Of Zepbound With Other Medications For Weight Management Have Not Been Established; Zepbound Contains Warnings For Pancreatitis, Gallbladder Problems, Hypoglycemia, Acute Kidney Injury, Diabetic Retinopat…

By Benzinga Newsdesk

November 8, 1:17 PM

https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-managementToday, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight

LLY

4 minute read

Samsung Bioepis & Organon Announce FDA Acceptance Of Supplemental Biologics License Application For Interchangeability Designation For HADLIMA, A Biosimilar To Humira

By Benzinga Newsdesk

November 7, 6:38 PM

sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued groupFiling

OGN

2 minute read

KORU Medical Systems, Inc. Receives FDA 510(k) Clearance For FREEDOM60 Infusion System With Hizentra 50 ML Prefilled Syringes

By Benzinga Newsdesk

November 7, 6:14 PM

KORU Medical Systems, Inc. (NASDAQ:KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty

KRMD