FDA Archives - Page 76 of 220

4 minute read

Celularity Announces Clinical Data On Human Placental-Derived Unmodified Allogeneic Natural Killer Cell Therapy Candidate Cynk-001 In Adult Patients With Relapsed Refractory And Measurable Residual Disease-Positive Acute Myeloid Leukemia

April 27, 9:24 AM

In patients with relapsed refractory acute myeloid leukemia (R/R AML) treated with a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose, two of four patients achieved an objective response at Day

CELU

2 minute read

Editas Medicine Receives FDA Orphan Drug Designation For EDIT-301 For The Treatment Of Sickle Cell Disease

By Happy Mohamed

April 27, 9:22 AM

Editas Medicine, Inc. (NASDAQ:EDIT), a clinical stage genome editing company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to EDIT-301, an investigational, gene

EDIT

1 minute read

PREVENT-19 Adolescent Data Published In The Journal Of The American Medical Association Network Open

By Happy Mohamed

April 27, 8:46 AM

https://ir.novavax.com/PREVENT-19-Adolescent-Data-Published-in-the-Journal-of-the-American-Medical-Association-Network-Open The full results from the pediatric expansion of Novavax’s Phase 3 PREVENT-19 trial

NVAX

1 minute read

Certara Customers Received 90% Of U.S. FDA Novel Drug Approvals For 9th Consecutive Year

By Happy Mohamed

April 27, 8:24 AM

Certara, Inc. (NASDAQ:CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Review

CERT

2 minute read

Aytu BioPharma Announces FDA Approval Of Adzenys XR-ODT(R)Manufacturing Site Transfer

By Happy Mohamed

April 27, 8:17 AM

U.S. Food & Drug Administration Approval of Prior Approval Supplement Enables Transfer of Adzenys Production to Contract Manufacturer in 2023 Upon Completion of Manufacturing Transfer of Adzenys XR-ODT and Cotempla

AYTU

1 minute read

Why Seres Therapeutics Shares Are Surging Thursday Morning

By Vandana Singh

April 27, 6:14 AM

Seres Therapeutics Inc (NASDAQ:MCRB) shares are up Thursday morning as the FDA approved Seres and Nestlé Health Science’s Vowst (fecal microbiota spores, live-brpk),…

MCRB

1 minute read

Inhibrx Resumes Patient Enrollment In INBRX-109 Studies In Cancer Patients

By Vandana Singh

April 26, 3:18 PM

Inhibrx Inc (NASDAQ:INBX) announced that the FDA lifted the partial clinical hold on studies evaluating its death-receptor 5 (DR5)…

INBX

2 minute read

Vertex Announces U.S. FDA Approval For TRIKAFTA In Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations

By Happy Mohamed

April 26, 1:38 PM

-About 900 children with cystic fibrosis will now have a medicine to treat the underlying cause of their disease for the first time- Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced the U.S. Food

VRTX

5 minute read

Committee For Medicinal Products For Human Use recommends EU Approval Of Roche’s Fixed-Duration Columvi For people With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

By Happy Mohamed

April 26, 1:06 PM

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma The recommendation is based on results from the phase

RHHBY

3 minute read

Amicus Therapeutics Receives Positive Committee For Medicinal Products For Human Use Opinion For Opfolda For Late-Onset Pompe Disease

By Happy Mohamed

April 26, 1:03 PM

European Commission Approval of Opfolda and Commercial Launch of Pombiliti® + Opfolda® Anticipated in 3Q 2023 Upon Approval, Pombiliti + Opfolda will be the

FOLD