MedPage Today15d
FDA Reviewers Voice Concerns Over Novel UTI Treatment
Ahead of an Antimicrobial Drugs Advisory Committee meeting on Monday, FDA reviewers voiced ongoing concerns about the ...
MedPage Today11d
FDA Advisors Question Potential Role of Novel Oral UTI Antibiotic
Potential for the development of antimicrobial resistance with sulopenem, as well as closely related carbapenems, was a major ...
Calgary Herald on MSN26d
Gout medicine could ease opioid withdrawal misery: U of C researchers
A team led by Dr. Lori Montgomery and Dr. Tuan Trang is seeking to firm up what appears to be a promising connection between ...
BioWorld13d
Adcom tries to balance risk for the many with benefit for the few
With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem ...
Verywell Health on MSN1y
How Long Does Amoxicillin Take to Start Working?
You may start to feel better within 48 to 72 hours. However, you should always finish taking all your prescribed medication, ...
Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women
FDA Decision Expected by PDUFA Goal Date of October 25, 2024Potential to be First Oral Penem Approved in the U.S.DUBLIN and CHICAGO, Sept. 10, ...
infectiousdiseaseadvisor.com12d
FDA Drug Approval Decisions Expected in October 2024
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
Lilly And EVA Pharma Collaborate To Expand Access To Baricitinib In Low- To Middle-Income Countries
Since 2021, EVA Pharma has been working with Lilly to ensure a sustainable supply of life-saving medicines across several ...
H.C. Wainwright维持Iterum股票买入评级，FDA专家组审查进行中
H.C. Wainwright维持Iterum Therapeutics (NASDAQ: ITRM)的买入评级，目标价为5.00美元。这一决定是在FDA抗菌药物咨询委员会(AMDAC)讨论该公司新药申请(NDA)之后做出的。 讨论的药物是sulopenem etzadroxil/probenecid（口服sulopenem），用于治疗成年女性的非复杂性尿路感染（uUTIs）。 AMDAC于周一召 ...
Iterum的口服抗生素在FDA咨询会议上讨论
都柏林和芝加哥 - 临床阶段制药公司Iterum Therapeutics plc (NASDAQ:ITRM)周一宣布,其口服抗生素sulopenem etzadroxil/probenecid的新药申请(NDA)近期在美国食品和药物管理局(FDA)咨询委员会会议上进行了讨论。抗微生物药物咨询委员会(AMDAC)于9月9日召开会议,讨论了该药物用于治疗成年女性单纯性尿路感染(uUTI)的情况。 在 ...