FDA Warns Exosome Maker for Marketing Outside Its IND
The FDA has warned Kimera Labs that it can’t sell its exosome product for uses outside of its recently secured investigational new drug (IND) application. In a warning letter that was posted to the FDA’s website last September, then removed, and then posted again this month, the agency also told the Miramar, Florida-based company that […]
17 Things Children Of Divorce Wish Their Parents Had Done Differently
Many of us are raised to believe that any family structure outside of the traditional, nuclear one is somehow “broken,” and that divorce causes children long-lasting harm. But when HuffPost asked folks to share the things they wish their parents had done differently surrounding divorce, people said again and again that they wished the divorce […]
Simone Biles To Return For First Meet Since Tokyo Olympics
Simone Biles is back. The gymnastics superstar plans to return to competition at the U.S. Classic outside Chicago in early August, her first event since the 2020 Tokyo Olympics. USA Gymnastics announced Wednesday that Biles, a seven-time Olympic medalist and the 2016 Olympic champion, is part of the women’s field for the single-day event set […]
Ocaliva for NASH Gets Thumbs Down From FDA Advisors
A panel of FDA’s outside experts said obeticholic acid (Ocaliva) does not have a favorable risk-benefit profile for treating nonalcoholic steatohepatitis (NASH) with pre-cirrhotic liver fibrosis, and recommended against accelerated approval of the drug. On Friday, the Gastrointestinal Drugs Advisory Committee voted 12-2 (with two abstentions) that the improvements in liver scarring seen in the […]
FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC
In a near-unanimous vote on Friday, outside advisors to the FDA recommended a narrow indication should the agency approve olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC). In an 11-1 vote (with one abstention), the Oncologic Drugs Advisory Committee (ODAC) recommended that any approval be restricted to patients with […]
CDC Alerts Docs to Watch for Potential Imported Marburg Cases
While there have been no confirmed cases of Marburg virus disease (MVD) outside Equatorial Guinea and Tanzania, clinicians and public health experts should be aware of the potential for imported cases, the CDC said. In a Health Alert Network advisory, the agency said that it is important for clinicians to assess patients for the possibility […]
Second RSV Vaccine for Older Adults Gets Thumbs Up From FDA Advisors
A panel of FDA’s outside advisors recommended the agency approve GSK’s respiratory syncytial virus (RSV) vaccine for older adults, a day after backing Pfizer’s RSV vaccine candidate for that same population. By votes of 12-0 on efficacy and 10-2 on safety, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the available data support […]
Nurses Go On Strike At 2 Big New York City Hospitals
NEW YORK (AP) — Striking nurses chanted and waved signs outside two large New York City hospitals Monday after a weekend of negotiations over pay and staffing levels did not produce a deal for a new contract. The walkout involves as many as 3,500 nurses at Montefiore Medical Center in the Bronx and about 3,600 […]
This Popular, Painful Massage Goes INSIDE Your Mouth. But Does It Work?
If you’ve ever had a facial, you’re probably familiar with the aesthetician massaging the outside of your cheeks. But have you ever had them massage the inside of your cheeks? It sounds strange, but that’s what a buccal facial massage is all about. While these massages have been around for some time, social media and […]
Opinion | My Patients Are My Heroes
I was standing outside the patient room, feeling slightly restless that day. A few days earlier, I had received some news from my doctor that I was not expecting. My mind sifted through the various possibilities and directions this could take me. When will I get to see my doctor to discuss this? What does […]