From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
US FDA approves Johnson & Johnson's device for heart condition
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
U.S. FDA proposes ending use of popular decongestant present in cold medicines
The U.S. Food and Drug Administration has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an ...
Pharmaceutical Technology2d
Autolus secures FDA approval for CAR-T cell therapy use in ALL
Autolus’ Aucatzyl is a B-lymphocyte antigen CD19 CAR-T cell therapy. Credit: NDAB Creativity via Shutterstock. Autolus ...
Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
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Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
FDA 510(k) Clearance Would Enable the Introduction of INBS&CloseCurlyQuote ... "will," "should," "approximately" or other ...
Medscape4d
FDA Approved Obe-cel, a Novel CD19 CAR T Product for ALL
Obe-cel was designed to increase T-cell persistence and reduce T-cell exhaustion and was shown to improve response rates and survival, particularly in patients with low leukemia burden.
Business Insider1d
Actuate Announces FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma
“Receiving rare pediatric disease designation from the FDA underscores the urgent need for new treatment ... that elraglusib could be associated with side effects, adverse events or other properties ...
Novavax: FDA removes clinical hold on Covid-19/flu combo trial
Novavax (NVAX) announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its ...
emjreviews.com1d
FDA Lifts Hold on COVID-Flu Combo Vaccine Trial
The FDA has lifted its clinical hold on Novavax's combined COVID-19 and influenza vaccine trial, finding no link between the ...
Bumble’s son is first British winner of ‘drug-free’ Las Vegas bodybuilding event
The son of David “Bumble” Lloyd, the legendary cricketer, commentator and coach, has become the first British winner of a ...
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PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
TORONTO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company” or "PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company ...