Tag: FDA

Ghanaian Pharmacist, Dr. Delese Mimi Darko Appointed Director General of the African Medicines Agency

Michael Gwarisa

By Michael Gwarisa Dr. Delese Mimi Darko has been appointed as the new Director General of the African Medicines Agency (AMA), marking a pivotal step toward strengthening health regulation and ensuring access to quality-assured medicines across Africa. With nearly three decades of experience in the medical and pharmaceutical fields, she brings deep expertise and a proven track record in medicine safety, regulation, and international collaboration. Beginning her career as a pharmacist, Dr. Darko later earned a Master’s in Business Administration. Her regulatory journey has spanned 28 years, during which she…

Read More

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

Michael Gwarisa

By HealthTimes Reporter The U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip. The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard…

Read More

First Injectable Treatment for HIV Pre-Exposure Prevention Approved

Healthtimes

THE United States (US) Food and Drug Administration approved Apretude or use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. Own Correspondent “Today’s approval adds an important tool in the effort to…

Read More

Coronavirus Mutation Causing High False Negative Results In Zim-Lancet

Michael Gwarisa

NEW Coronavirus strains being reported worldwide could be the reason why most Laboratories in Zimbabwe have been recording high cases of false negative COVID-19 results of late, a top pathologist has said. By Michael Gwarisa Speaking during a virtual press briefing, Lancet Laboratories Chief Executive Officer, Dr Charlse Muronda said the viruses have changed their genetic makeup , in the process making it difficult for other  organisations which have not upgraded their testing equipment to pick the virus during testing procedures. One of the things that have happened with COVID-19…

Read More