FDA Newsfeed
Choose content
Create your own custom newsfeed
|
Set preferences
Set up your newsfeed details, look and feel and desired output
|
Create account
Enter your registration information
|
-
FDA Receives Application to Review D-VRd in Multiple Myeloma Subset
05 Oct 2024 21:40 GMT
Cure Today
… the Food and Drug Administration (FDA) to potentially approve a … license application to the FDA when seeking approval of … “We’re encouraged that the FDA Oncologic Drugs Advisory Committee recently … previously approved by the FDA for other indications and …
-
FDA warns of 'serious' reaction or 'death' from recalled eggs
05 Oct 2024 20:03 GMT
Democrat & Chronicle - New York
… supplied by its farm, the FDA said. The recalled eggs … are fully cooperating with the FDA on their investigation and have … being recalled? According to the FDA, all carton sizes with expiration … if they contract salmonella, the FDA said. Ahjané Forbes is …
-
Palvella Therapeutics awarded up to $2.6 mn grant from US FDA OOPD to support phase 3 SELVA trial in in microcystic lymphatic malformations
05 Oct 2024 12:03 GMT
Pharmabiz.com
… Food and Drug Administration (FDA) Office of Orphan Products … consultation with the relevant FDA review division to help … . Since inception, the FDA Orphan Products Grants Program … . Qtorin rapamycin has received FDA Breakthrough Therapy Designation, Fast …
-
FDA Approves 16 New Cancer Treatments as Global Cancer Rates Skyrocket
05 Oct 2024 10:40 GMT
L A Downtown News - California
… Cancer Treatments, Prepares for FDA Accelerated Approval Path Oncolytics Biotech … designed to support an accelerated FDA approval. As well, … plans to submit to the FDA a pelareorep + paclitaxel … Application (BLA) to the FDA for accelerated approval of …
-
Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path
05 Oct 2024 10:40 GMT
L A Downtown News - California
… recent feedback from the FDA, give us confidence in … plan to submit to the FDA a pelareorep + paclitaxel combination … Fast Track designation from the FDA. For further information, please … -cancer-treatments-prepares-for-fda-accelerated-approval-path-302267617. …
-
Lupin's Pune-based biotech facility gets 5 observations from US FDA
05 Oct 2024 09:10 GMT
Business Standard
… said that the U.S. FDA has completed a pre-approval … respond to the U.S. FDA within the stipulated timeframe. Mumbai …
-
US FDA approves perioperative treatment of neoadjuvant Opdivo & chemotherapy followed by surgery and adjuvant single─agent Opdivo for resectable NSCLC
05 Oct 2024 07:02 GMT
Pharmabiz.com
… US Food and Drug Administration (FDA) approved Opdivo (nivolumab) for … foundation set by the FDA approval of neoadjuvant-only … or unacceptable toxicity. The FDA previously approved Opdivo for adult … have been approved by the FDA in the neoadjuvant, adjuvant …
-
OncLive’s September Roundup of Key FDA Approvals in Oncology
05 Oct 2024 02:29 GMT
OncLive
… the therapeutic options that the FDA has approved in September 2024 … chemotherapy was approved by the FDA for the first-line … ) was approved by the FDA for use in adult patients … On September 27, 2024, the FDA granted traditional approval to selpercatinib …
-
MIM Software Receives FDA Clearance for Theranostics Portfolio
05 Oct 2024 00:40 GMT
Imaging Technology News - New Jersey
… .S. Food and Drug Administration (FDA) to perform absorbed dose calculation … at large with the recent FDA clearance,” said Yuni Dewaraja, PhD …
-
Atsena lands another FDA incentive for gene therapy to fight blindness
04 Oct 2024 23:41 GMT
NCBiotech Center - North Carolina
… . Food and Drug Administration (FDA) to help boost the development … leading product candidate. The FDA has granted Atsena an Orphan … . In late August, the FDA also granted Rare Pediatric Disease … our path forward.” The FDA grants Orphan Drug Designation to …
-
FDA Approves Opdivo for Resectable Non-Small Cell Lung Cancer
04 Oct 2024 23:41 GMT
American Pharmaceutical Review
The FDA approved nivolumab Bristol Myers Squibb’ … the applicant to facilitate the FDA’s assessment. Subscribe to our …
-
A New FDA Ruling Can Help Black Women in the Fight Against Breast Cancer. What You Should Know
04 Oct 2024 23:06 GMT
EBONY
… . The Food and Drug Administration (FDA) recently issued a ruling that …
- FDA greenlights Exact Sciences’ Cologuard Plus 04 Oct 2024 23:23 GMT BioWorld
-
US FDA puts Kezar Life Sciences' lupus treatment trial on hold after patient deaths
04 Oct 2024 22:44 GMT
The Gazette - Colorado
… company said on Friday. The FDA's decision comes after …
-
Nivolumab Approved as Neoadjuvant, Adjuvant Therapy for NSCLC by FDA
04 Oct 2024 22:13 GMT
The American Journal of Managed Care
The FDA has approved nivolumab (Opdivo; Bristol … approval came days before the FDA’s expected Prescription Drug User … acceptance in February to the FDA and the European Medicines Agency … approval also marks the fifth FDA-approved indication for nivolumab in …
-
5 FDA Decisions to Watch in Q4 2024
04 Oct 2024 21:57 GMT
Consultant Live
… -302181549.html. Campbell P. FDA approves Sotagliflozin for treatment of … Pharmaceuticals, Inc. Lexicon Pharmaceuticals announces FDA Advisory Committee meeting for zynquista … /Lexicon-Pharmaceuticals-Announces-FDA-Advisory-Committee-Meeting-for-Zynquista …
-
FDA Approves Cologuard Plus Stool DNA Test for Colorectal Cancer Screening
04 Oct 2024 21:38 GMT
Targeted Oncology
The FDA has approved the Cologuard Plus … Islander. In May 2024, the FDA approved ColoSense, another noninvasive stool … years of age. REFERENCES: 1. FDA approves Exact Sciences’ Cologuard Plus … tinyurl.com/tzh2b9fp 2. FDA approves ColoSense™ - Geneoscopy…
-
Next-generation CRC test earns FDA approval
04 Oct 2024 21:26 GMT
Becker's ASC Review
The FDA has approved the Cologuard Plus … risk for colorectal cancer. The FDA's approval was based …
-
Corin wins FDA nod for Unity Knee tibial insert for robot-assisted TKA
04 Oct 2024 21:26 GMT
MassDevice
… ]Corin announced that it received FDA 510(k) clearance for its …
-
FDA clears hip arthroplasty tech from OrthAlign
04 Oct 2024 21:26 GMT
MassDevice
… ]OrthAlign announced that it received FDA 510(k) clearance for its …
-
STAT+: Exact Sciences wins FDA approval for improved stool-based colon cancer test
04 Oct 2024 21:23 GMT
STAT - Massachusetts
… unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus …
-
FDA Approves Cologuard Plus, Next-Gen Noninvasive Colorectal Cancer Screening Test
04 Oct 2024 20:55 GMT
Patient Care
The US FDA today approved Cologuard Plus, … specificity reported in the original FDA registrational trial for Cologuard.3 … at Exact Sciences, concluded.1 FDA approves Exact Sciences’ Cologuard … /press-releases/fda-approves-exact-sciences-cologuard-plus …
- US FDA puts clinical hold on Kezar Life Sciences' lupus treatment trial 04 Oct 2024 21:25 GMT The Gazette - Colorado
-
FDA Clears Automated Dosimetry with the Monte Carlo Method for Radionuclide Therapy
04 Oct 2024 20:27 GMT
Diagnostic Imaging
… , the Food and Drug Administration (FDA) has granted 510(k) clearance … at large with the recent FDA clearance,” said Yuni Dewaraja, PhD …
-
Muffin Recall Update As FDA Sets Risk Level
04 Oct 2024 20:10 GMT
Newsweek
… .S. Food and Drug Administration (FDA) has classified the recall as … as Class II by the FDA Smith Collection/Gado… remote," according to the FDA. More From Newsweek Vault: What … Walgreens. As stated in the FDA recall notice, the muffins contained …