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
|
-
Laboratory-Developed Tests Set To Be Regulated By The FDA
18 May 2024 17:44 GMT
World Pharma Today
The FDA’s final rule that solidifies … the next four years, the FDA is going to phase out … . According to Robert Califf, the FDA Commissioner, the agency cannot stand … the critical tests development. The FDA maintains rectifying imbalances in oversight …
-
BLA for Subcutaneous Nivolumab Accepted by the FDA for Advanced/Metastatic Solid Tumors
18 May 2024 16:39 GMT
Oncology Nursing News
… Cabometyx).1 Notably, the FDA assigned a Prescription Drug … . If approved by the FDA, the subcutaneous administration of … ipilimumab combination therapy received FDA approval in October 2015 … aspx Opdivo. Prescribing information. FDA; April 2018. Accessed May …
-
Mayor Robes, FDA exec discuss possible assistance for SJDMC MSMEs
18 May 2024 15:34 GMT
Politiko
… welcomed Food and Drug Administration (FDA) Region III North Luzon Cluster … mga kaukulang proseso upang maging FDA-approved ang mga produkto ng … excited nang maging katuwang ang FDA Region III sa pagtiyak na …
-
FDA Updates for Week of May 13: First Bispecific Antibody for Solid Tumor
18 May 2024 15:11 GMT
Managed Healthcare Executive
… was 14.3 months. FDA Approves Breyanzi for Follicular Lymphoma … The FDA has granted accelerated approval … for Enzyme Deficiency The FDA has accepted the biologics … application (BLA) to the FDA for a subcutaneous autoinjector for …
-
Dosing Commenced in Study of Anti-Tau Agent, FDA Updates Labeling to Glatiramer Acetate Products, Eisai Initiates Rolling Submission for Subcutaneous Lecanemab
18 May 2024 11:30 GMT
NeurologyLive
… impact on pathological tau. The FDA has issued an update to … of lecanemab (Leqembi; Eisai), an FDA-approved therapy for early-stage … license application (BLA) to the FDA for a subcutaneous autoinjector version …
-
WOMEN'S HEALTHCARE COMPANY WATKINS-CONTI RECEIVES FDA 510(K) CLEARANCE FOR NEW STRESS URINARY INCONTINENCE DEVICE YŌNI.FIT®
18 May 2024 08:59 GMT
Press Publications/Kanabec.com
… .S. Food and Drug Administration (FDA) for Yōni.Fit® Bladder Support … general control over symptoms. The FDA clearance represents a substantial milestone … challenging." "With this FDA clearance, Watkins-Conti is now …
-
US FDA grants breakthrough therapy designation to Nuvalent's NVL─655 to treat locally advanced or metastatic ALK─positive NSCLC
18 May 2024 08:42 GMT
Pharmabiz.com
… US Food and Drug Administration (FDA) has granted breakthrough therapy designation … ;Today's announcement of FDA breakthrough therapy designation for NVL … therapies. Under the designation, the FDA provides intensive guidance, organizational commitment …
-
Amgen's Imdelltra receives US FDA approval to treat adult patients with extensive─stage small cell lung cancer
18 May 2024 06:17 GMT
Pharmabiz.com
… Food and Drug Administration (FDA) has approved Imdelltra (tarlatamab … cancers through our second FDA-approved Bispecific T-cell … "Today's FDA approval marks a significant milestone … aggressive disease." The FDA accelerated approval of Imdelltra …
-
Bristol Myers Squibb's CAR T cell therapy Breyanzi receives US FDA approval for relapsed or refractory follicular lymphoma
18 May 2024 04:41 GMT
Pharmabiz.com
… Myers Squibb announced the US FDA has granted accelerated approval for … Sloan Kettering Cancer Center. “The FDA approval of liso-cel for …
-
FDA Roundup: May 17, 2024
18 May 2024 04:18 GMT
U.S. Food and Drug Administration
… . On Wednesday, the FDA granted accelerated approval to … constipation, and fever. The FDA approved lisocabtagene maraleucel with … On Wednesday, the FDA published the FDA Voices: “Protecting and … outreach. On Wednesday, the FDA announced a webinar: Enforcement …
-
FDA cracks down on properties converted illegally to commercial
18 May 2024 02:05 GMT
The Nation
… - The Faisalabad Development Authority (FDA) is continuing a vigorous crackdown …
-
FDA Roundup: Updated Label for Altuviiio, CRL Given to Heplisav-B
18 May 2024 01:32 GMT
Drug Topics
… in Europe remains unchanged. FDA Approves Tarlatamab-dlle for Extensive … Cell Lung Cancer The FDA granted accelerated approval to … syndrome, according to the FDA. Amgen noted that the continued … 2 virus. READ MORE: FDA Updates Resource Center Pharmacy practice …
-
Brainomix swings FDA clearance for its lung imaging AI software
17 May 2024 23:46 GMT
Medical Device Network
… US Food and Drug Administration (FDA) off the back of a … using proprietary imaging biomarkers. The FDA clearance follows a phase II … treatment decisions. “This e-Lung FDA clearance reflects our focus on …
-
FX Shoulder obtains FDA 510(k) clearance for glenoid baseplates
17 May 2024 23:46 GMT
Medical Device Network
… US Food and Drug Administration (FDA) for its full-wedge augmented … the market.” In 2022, the FDA issued 510k approval for FX …
- FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer 17 May 2024 23:03 GMT BioWorld
-
Illinois lawmakers profess better science than FDA, plan to ban some food ingredients
17 May 2024 23:05 GMT
Illinois Policy
The Illinois Senate approved legislation banning four food additives, sending it to the House. Manufacturers will need to sell an alternate recipe in Illinois if the bill becomes law. Store-brand sodas, breads, pastries and candies could soon be outlawed …
-
The FDA Grants Accelerated Approval to Tarlatamab-dlle in Small Cell Lung Cancer
17 May 2024 22:33 GMT
Pharmacy Times
The FDA has granted accelerated approval to … release. "Today's FDA approval marks a significant milestone … , and nausea.3 "The FDA's approval of IMDELLTRA … aggressive cancers through our second FDA-approved Bispecific T-cell Engager …
-
Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease
17 May 2024 21:50 GMT
Fierce Pharma
… as a “watershed moment,” the FDA has signed off on Imdelltra … . Over the last decade, the FDA has approved Blincyto for five …
-
WITHDRAWN: FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma
17 May 2024 21:44 GMT
U.S. Food and Drug Administration
… detected by an FDA-approved test. The FDA also approved … , an initiative of the FDA Oncology Center of Excellence. … partners. For this review, FDA collaborated with the Australian Therapeutic … applicant to facilitate the FDA’s assessment. This application …
-
Medtronic capsule endoscopy kit cleared by FDA
17 May 2024 21:11 GMT
Becker's ASC
… has been approved by the FDA. The PillCam Genius SB capsule …
-
NVL-655 Receives FDA Breakthrough Therapy Designation in ALK+ NSCLC
17 May 2024 20:44 GMT
Cancer Network - New Jersey
The FDA has granted breakthrough therapy … “Today's announcement of FDA breakthrough therapy designation for NVL … Based on alignment with the FDA, the recommended phase 2 dose … daily. Nuvalent receives U.S. FDA breakthrough therapy designation for NVL …
-
FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer
17 May 2024 20:38 GMT
Drug Topics
… syndrome, according to the FDA.3 Amgen noted that the … breakthrough therapy designation by the FDA. The application process was … , an initiative from the FDA Oncology Center of Excellence providing … cancers through our second FDA-approved Bispecific T-cell …
-
Amgen Cancer Drug Wins FDA Nod
17 May 2024 20:27 GMT
MENAFN
… , 2024 Amgen Cancer Drug Wins FDA Nod The U.S. Food …
-
FDA Roundup: May 17, 2024
17 May 2024 20:01 GMT
U.S. Food and Drug Administration
… . On Wednesday, the FDA granted accelerated approval to … constipation, and fever. The FDA approved lisocabtagene maraleucel with … On Wednesday, the FDA published the FDA Voices: “Protecting and … outreach. On Wednesday, the FDA announced a webinar: Enforcement …