English

fda-0 / English

Stories published in last 24 hours
  • Related stories in the last 90 days
  • Stories published in last 24 hours

Monday, May 27

11

Nigerians abroad: Onyedika is FDA champion; heartbreak for Osayi-Samuel; Dele-Bashiru, Okoye beat relegation (Videos)

soccernet.ng

Soccernet.ng kept tabs on dozens of matches potentially featuring Nigerian footballers across different leagues worldwide on Sunday, May 26, 2024. Algeria Tosin Omoyele scored his sixth goal of the season to power Khenchela to a hard…

Friday, Mar 8

01

Illinois company recalls imported cinnamon after FDA warns public about lead in product

Raja Foods LLC of Skokie, Il, is recalling its 3.5-ounce packages of “Swad Cinnamon Powder” because it has the potential to be contaminated with lead. The products included in this recall are, Swad Brand Cinnamon Powder in clear plastic 3…

Thursday, Aug 24

15

Regulatory Setback For Medtronic's High Blood Pressure Device - FDA Backed Japanese Firms' Similar Device For Uncontrolled Hypertension

www.benzinga.com

Medtronic Plc (NYSE: MDT) says the FDA Circulatory System Devices Panel (CSDP) voted unanimously (13-0) on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure, Spyral Renal Denervation (RDN) System.

Wednesday, Jun 21

13

Omicron: FDA backs updated COVID-19 vaccines targeting XBB variants

www.tvcnews.tv

A US Food and Drug Administration (FDA) panel of advisors has unanimously recommended that updated COVID-19 vaccines being developed for the autumn vaccination campaign target one of the currently circulating XBB variants. The advisory…

Thursday, Jun 15

00

FDA Approves New COVID Booster Focusing Only on Variants

www.webmd.com

The action follows a key advisory committee's 21-0 vote that a new vaccine should focus on just one strain of the virus, and not be a bivalent shot as before.

Friday, Jun 9

23

FDA advisers endorse Alzheimer's drug for full approval

thehill.com

Outside advisers to the Food and Drug Administration (FDA) on Friday unanimously recommended the agency grant full approval to a new kind of Alzheimer's drug that modestly slows cognitive decline in early-stage patients. The panel voted 6…

Thursday, Jun 8

00

Press Release: FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants

www.benzinga.com

Paris, June 8, 2023. The U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 21 to 0 that Sanofi and AstraZeneca's nirsevimab has a favorable benefit risk profile for the prevention of…

Wednesday, May 10

20

Advisers to the FDA back first over-the-counter birth control pill

www.npr.org

In a unanimous vote, 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill.

Tuesday, Apr 18

16

FDA's AdComm Panel Favors Innoviva's Drug For Multidrug-Resistant Bacterial Infections

www.benzinga.com

The FDA's Antimicrobial Drugs Advisory Committee unanimously voted 12-0 in support of approval of Innoviva Inc's (NASDAQ: INVA) sulbactam-durlobactam for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia…

Thursday, Mar 23

13

FDA Adcomm Says Benefit-Risk Profile Favor Biogen's Tofersen For Inherited Neuro Disorder

www.benzinga.com

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 9 yes - 0 no, indicating sufficient evidence showing a reduction in plasma neurofilament light chain (NfL) concentration in tofersen-treated patients is…

Thursday, Mar 2

FDA Fuels Respiratory Syncytial Virus Vaccine Race While Backing GSK's Candidate Soon After Pfizer's

www.benzinga.com

The FDA's Vaccines and Related Biological Products Advisory Committee voted that GSK plc's (NYSE: GSK) available data support the safety and effectiveness of its respiratory syncytial virus (RSV) candidate to prevent lower respiratory…

Thursday, Feb 16

01

FDA advisers recommend approval of Narcan for over-the-counter use

thehill.com

The anti-opioid overdose drug Narcan should be made available for over-the-counter use, advisers to the Food and Drug Administration said Wednesday. A joint FDA advisory panel unanimously voted 19-0 to recommend the agency approve the drug…

Monday, Feb 13

14

Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients

www.prnewswire.com

The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit…

Thursday, Dec 29

16

FDA Authorizes TransCode's First-In-Human Clinical Trial With Solid Tumor Patients

www.benzinga.com

TransCode Therapeutics Inc (NASDAQ: RNAZ) has received written authorization from the FDA to proceed with its First-in-Human (FIH) Phase 0 clinical trial.; The planned clinical trial is to evaluate TransCode's lead therapeutic candidate,…

Thursday, Nov 3

18

StockWatch: FDA Panel’s Rebuff on Cancer mAb Hammers Y-mAbs Shares

www.genengnews.com

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 that Y-mAbs had not provided sufficient evidence to conclude that omburtamab improved overall survival despite positive results from two studies, the single-arm, Phase I Study…

Wednesday, Jun 15

23

FDA advisers recommend authorization for Moderna’s COVID shot in kids 5 and under – Nashville-Davidson, Tennessee

eminetra.com

Nashville-Davidson, Tennessee 2022-06-15 15:38:08 – ((((Hill) — Wednesday’s external Food and Drug Administration (FDA) advisory board unanimously recommended granting an emergency use authorization for Moderna’s COVID-19 vaccine for…

Tuesday, Jun 14

Panel recommends FDA authorize Moderna vaccine for kids, teens 6 to 17

thehill.com

A Food and Drug Administration (FDA) advisory panel on Tuesday recommended the agency expand the authorization of Moderna's COVID-19 vaccine to children and teenagers ages 6 to 17. The vaccine is currently approved for adults only. The…

Wednesday, Jun 8

04

FDA Panel Strongly Backs Protein-Based Novavax COVID Vaccine

www.medscape.com

FDA advisers voted 21-0 in favor of the Novavax COVID vaccine, which is based on older, more conventional technology than mRNA shots. Advocates for this shot see it as likely to win over some vaccine-hesitant people. Medscape Medical News

01

Novavax's COVID-19 Vaccine For Adults Over 18 Backed By FDA Advisors: What's Next?

www.benzinga.com

Novavax, Inc. (NASDAQ: NVAX) announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use…

Tuesday, Jun 7

22

FDA panel gives nod to Novavax COVID-19 shot

thehill.com

An outside advisory panel voted overwhelmingly to recommend the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, a move that could lead to adding a fourth vaccine to the U.S. arsenal. The…