Dr. Reddy’s generic twice-yearly lenacapavir received FDA tentative approval for HIV PrEP. It is expected to cost $40 a year in 120 llow- and middle-income countries (LMICs), with first supplies due by the end of 2026.
|Articles|April 25, 2020
The ID Pipeline: FDA Activity From the Week of April 19, 2020
Author(s)Contagion® Editorial Staff
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 19, 2020.
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Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 19, 2020.
FDA Approves Sanofi's Quadrivalent Meningococcal Vaccine
The US Food and Drug Administration has
MenQuadfi is the only FDA approved quadrivalent meningococcal vaccine that is indicated for individuals 2 through 56 years of age and older.
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FDA Grants EUA to LabCorp's At-Home COVID-19 Test Kit
The US Food and Drug Administration (FDA) has issued an
Under this authorization, nasal swab specimens can be collected at home using the Pixel by LabCorp COVID-19 collection kit. A health care provider must recommend the test and patients must complete a COVID-19 questionnaire prior to testing.
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David Altarac, MD, discusses 2025 SENTRY data, ESBL considerations in empiric therapy, and where ceftobiprole fits alongside ceftaroline in S aureus bacteremia.
A Yakima County resident exposed to infected dairy cattle has died of avian influenza. A third human case has also been confirmed as H5N1 spreads to 33 herds in the county.
Jean van Wyk, MBChB, MFPM, discussed the 5-year OPERA data from IDWeek 2026 as well as the anticipated CROWN study results.
Voceryq earned FDA accelerated approval for adults with RRP after 7 of 26 patients (27%) needed no surgery for 12 months in RRP-001; a confirmatory trial is required.
Cefiderocol MICs fell against Pseudomonas aeruginosa and Klebsiella pneumoniae, and the drug showed marked synergy with LL-37 against resistant Acinetobacter baumannii. Jacinda Abdul-Mutakabbir, PharmD, MPH, AAHIVP, discusses her team's findings around this therapy and these pathogens.
In a national survey of 959 US adults, 27.9% said they had exaggerated or made up symptoms to obtain antibiotics, most often cold-like symptoms, with implications for outpatient stewardship.
The CDC reports the Bundibugyo virus outbreak in the Democratic Republic of the Congo (DRC) is now the second-largest Ebola outbreak on record. As of October 28, the agency counted 10,305 total confirmed cases and 4,996 total confirmed deaths. The overall risk to the American public and travelers remains low, and no cases tied to this outbreak have been confirmed in the US.
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