FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

At a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has contributed to widespread skepticism, undervaccination, and ultimately unnecessary deaths from covid-19. The committee voted unanimously Thursday to support the FDA’s […]

Read more

FDA Approves Semglee (insulin glargine-yfgn) as First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product […]

Read more

Journalists Dig in on Delta Variant Risks and Opioid Overdose Deaths

KHN Midwest correspondent Lauren Weber discussed outbreaks caused by the covid-19 delta variant in Missouri and elsewhere on Newsy on Thursday. Click here to watch Weber on Newsy Read Weber’s “The Delta Variant Thrives in a State of Political and Public Health Discord“ KHN correspondent Aneri Pattani discussed opioids and the rise in overdose deaths on Newsy’s “Morning Rush” on […]

Read more

FDA Approves Vaxneuvance

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults KENILWORTH, N.J.–(BUSINESS WIRE)– (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae […]

Read more

FDA Approves Rylaze

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]

Read more

You’ve Added Your Kids to Your Health Plan. What About Mom?

SACRAMENTO — When Laura Chavez’s 74-year-old mom needed eye surgery last month, Chavez paid cash for the procedure. The cost? $15,000 — and that was for just one eye. She couldn’t afford both. Her mom, Esperanza Chavez, doesn’t qualify for Medicare because of her immigration status. And she can’t find a private health insurance plan under $1,000 a month. “We’re […]

Read more

Doctors More Likely to Prescribe Opioids to Covid ‘Long Haulers,’ Raising Addiction Fears

Covid survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say. A new study in Nature found alarmingly high rates of opioid use among covid survivors with lingering symptoms at Veterans Health Administration facilities. About 10% of covid survivors develop “long covid,” […]

Read more

FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data […]

Read more
1 2 3 21