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Alebund's Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
29 Mar 2024 15:38 GMT
Asiaone
… US Food and Drug Administration (FDA) has granted Orphan Drug Designation … Orphan Drug Designation by the FDA", Dr. Gavin Xia, Co … living with ADPKD. The US FDA's ODD is a …
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FDA Extends Review Period for Applied Therapeutics’ Govorestat by Three Months
29 Mar 2024 15:22 GMT
BioSpace
… on Thursday announced that the FDA is extending the review … routine information requests, which the FDA considered a major amendment to … to work closely with the FDA throughout the review process.” … govorestat’s NDA—which the FDA accepted and granted Priority …
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LISCure Biosciences receives U.S. FDA Fast Track designation for LB-P8 for the treatment of primary sclerosing cholangitis (PSC)
29 Mar 2024 15:38 GMT
Asiaone
… for the treatment of PSC FDA's Fast Track designation … .S. Food and Drug Administration (FDA) has granted Fast Track designation … for enhanced communication between the FDA and sponsors, with the goal …
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73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis
29 Mar 2024 15:38 GMT
Asiaone
… Drug Designation (ODD) by the FDA for the treatment of breast … rate of 74.4%. The FDA granted ODD to utidelone injectable … , an ODD granted by the FDA provides many incentives such as …
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Could the FDA ban chemical in decaf coffee? Agency is looking into whether substance used by Starbucks and Dunkin' Donuts to strip out caffeine may cause CANCER
29 Mar 2024 12:55 GMT
Daily Mail
… show could cause cancer. The FDA is currently considering a petition … with a response from the FDA expected within 90 days. As … with the Delaney Clause, the FDA's rigorous scientific analysis … — considering a similar move. The FDA has also announced that it …
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FDA extends review period for Applied Therapeutics’ govorestat NDA
29 Mar 2024 12:11 GMT
Pharmaceutical Technology
… US Food and Drug Administration (FDA) has announced a three-month … rare genetic metabolic disease. The FDA has requested more time to … to work closely with the FDA throughout the review process. “During …
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AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD
29 Mar 2024 15:20 GMT
Pharmaceutical Technology
FDA has approved AstraZeneca's … originally published on BioPharmInternational.com. FDA has approved Ultomiris (ravulizumab-cwvz … , and brain. With today’s FDA approval, patients now have the …
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FDA may consider ban on chemical in decaf coffee over cancer concerns
29 Mar 2024 14:52 GMT
New York Post
… when they read this. The FDA may ban a chemical in … ban the chemical, and the FDA is currently considering it and … coffee being evaluated by the FDA. The Washington Post/Getty … foods is still under the FDA’s Federal Food, Drug and …
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What to know about the FDA's new effort to ban a shock device only used at this Mass. school
29 Mar 2024 12:03 GMT
WBUR - Massachusetts
… the news: Round two: The FDA is going back to battle … failed.” However, according to the FDA, the shock devices raise psychological … battle over the issue. The FDA first issued a ban on … once again prevail.” Meanwhile, the FDA — which expects to issue a …
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SyntheticMR gets FDA nod for quantitative syMRI 3D software
29 Mar 2024 15:11 GMT
DOTmed
SyntheticMR's SyMRI 3D software SyntheticMR has scored 510(k)-clearance for its next-generation quantitative MR software, SyMRI 3D, equipped with isotropic 3D resolution to more precisely estimate brain region volume and improve lesion analysis. More …
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Ischemic Stroke Market Forecast 2032: Epidemiology, FDA Approvals, Key companies, and Market Projections by DelveInsight
29 Mar 2024 12:30 GMT
EIN Presswire
Ischemic Stroke companies ALBANY, NEW YORK, UNITED STATES, March 29, 2024 /EINPresswire.com/ -- "Ischemic Stroke Market Insights, Epidemiology and Market Forecast– 2032" by DelveInsight provides a comprehensive analysis of Ischemic …
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Borealis’ Borcycle M gets FDA approval for food-grade packaging use
29 Mar 2024 11:18 GMT
Packaging Gateway
… Borealis stated that the FDA has granted two LNOs … and other regions under FDA jurisdiction. In the European … enhance plastics circularity. The FDA’s approval will contribute to … other sustainable offerings, this FDA clearance of selected grades of …
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ProJenX Announces Removal of Partial Clinical Hold for Prosetin Program by FDA
29 Mar 2024 09:01 GMT
BioSpace
… States Food and Drug Administration (FDA) has removed a partial clinical … , we are very pleased that FDA has lifted this partial clinical … Officer at ProJenX. "The FDA's decision allows us … hold-for-prosetin-program-by-fda-302101883.html SOURCE ProJenX
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Applied Therapeutics Says FDA Extends Review Period Of NDA For Govorestat
29 Mar 2024 06:48 GMT
RTTNews
… . Food and Drug Administration or FDA has extended the review period … months to November 28. The FDA noted that it requires additional … company had announced that the FDA accepted and granted priority review …
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Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue
29 Mar 2024 05:09 GMT
BioSpace
… .S. Food and Drug Administration (FDA) cleared the investigational new drug … -releases/nested-therapeutics-announces-fda-clearance-of-investigational-new-drug …
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Siemens Healthineers gets FDA nod for new 7T MR
29 Mar 2024 04:09 GMT
DOTmed
… a green light from the FDA now secured, Siemens Healthineers has …
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An ActRIIA fusion protein got FDA approved for PAH treatment
29 Mar 2024 03:57 GMT
Medical News
… On March 26th, the US FDA granted approval for Merck’s …
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Endostart granted FDA clearance for Endorail colonoscopy device
29 Mar 2024 01:59 GMT
BioWorld
… .r.l. received U.S. FDA 510(k) clearance for Endorail … MedTech Regulatory Gastrointestinal U.S. FDA
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FDA warns of some over-the-counter topical pain relief products
29 Mar 2024 01:27 GMT
WXYZ - Michigan
… at higher concentrations than the FDA permits for over-the- … names on the FDA’s website at fda.gov, The FDA has sent … the law. Otherwise, the FDA will consider legal action including … and distribution. Meanwhile, the FDA has these recommendations for consumers …
- Setting the Record Straight on the FDA Case at the Supreme Court 29 Mar 2024 01:28 GMT National Review
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FDA expands chronic HBV treatment to patients as young as 6 years
29 Mar 2024 00:49 GMT
Contemporary Pediatrics
… ) has been approved by the FDA to treat chronic hepatitis B … exacerbation of hepatitis B. Reference: FDA expands indication for Gilead… /2024/3/fda-expands-indication-for-gileads-vemlidy …
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FDA Approves Expanded Indication for Tenofovir Alafenamide as Hepatitis B Treatment
29 Mar 2024 00:44 GMT
Pharmacy Times
The FDA has approved a supplemental new … that was approved by the FDA for the treatment of chronic … of hepatitis B.1 References FDA Expands Indication for Gilead… /2024/3/fda-expands-indication-for-gileads-vemlidy …
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FDA Approves Ravulizumab-cwvz for Rare Autoimmune Disease
29 Mar 2024 00:25 GMT
The American Journal of Managed Care
On Monday, the FDA approved a label expansion for … interval.” "With today’s FDA approval, patients now have the …
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FDA Authorizes New COVID-19 Prevention for Immunocompromised People
28 Mar 2024 22:23 GMT
POZ
… the Food and Drug Administration (FDA) granted emergency use authorization for … In late 2021, the FDA approved a monoclonal antibody combination … vaccination,” according to the FDA. It is authorized only … with long COVID. The FDA authorization was based on so …
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BD to Increase Plastic Syringe Production After FDA Warns on Imports From China
28 Mar 2024 22:18 GMT
Drug Topics
… to recommendations from the FDA that health care providers avoid … and product examinations, the FDA’s quality concerns have continued … an infusion pump, the FDA urged providers to “immediately … drug delivery hardware. “The FDA believes that the supply and …