Search results for "FDA update"
New COVID-19 vaccines approved for certain groups
The FDA approved new COVID-19 vaccines from Moderna and Novavax and a test for Alzheimer's, among other recent actions.
https://acphospitalist.acponline.org/archives/2025/06/11/new-covid-19-vaccines-approved-for-certain-groups.htm
11 Jun 2025
New FDA commissioner sworn in
The FDA approved fitusiran, a new treatment for hemophilia, and tenecteplase to treat ischemic stroke, among other recent actions.
https://acphospitalist.acponline.org/archives/2025/04/30/new-fda-commissioner-sworn-in.htm
30 Apr 2025
First rapid-acting insulin biosimilar approved
The FDA approved a biosimilar to rapid-acting insulin aspart, among other recent actions.
https://acphospitalist.acponline.org/archives/2025/03/12/first-rapid-acting-insulin-biosimilar-approved.htm
12 Mar 2025
Nonopioid approved for moderate to severe pain
The medication, suzetrigine, is a first-in-class drug, targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, and was tested on patients with pain following abdominoplasty and bunionectomy.
https://acphospitalist.acponline.org/archives/2025/02/12/nonopioid-approved-for-moderate-to-severe-pain.htm
12 Feb 2025
GLP-1 receptor agonists get expanded indication, new generic
The FDA approved tirzepatide, a glucagon-like peptide-1 (GLP-1) and dual glucose-dependent insulinotropic polypeptide receptor agonist, for obstructive sleep apnea in some patients, as well as a generic for liraglutide, among other actions.
https://acphospitalist.acponline.org/archives/2025/01/08/glp-1-receptor-agonists-get-expanded-indication-new-generic.htm
8 Jan 2025
Sickle cell drug withdrawn from market
The FDA recently announced that voxelotor was being removed from the market, along with several ventilator- and pump-related recalls, among other actions.
https://acphospitalist.acponline.org/archives/2024/11/06/sickle-cell-drug-withdrawn-from-market.htm
6 Nov 2024
FDA approves self-administration of nasal flu vaccine
The FDA announced that the nasal spray vaccine may now be administered by patients and caregivers, among other recent actions. A prescription is still required.
https://acphospitalist.acponline.org/archives/2024/10/02/fda-approves-self-administration-of-nasal-flu-vaccine.htm
2 Oct 2024
Updated COVID-19 vaccines approved
The FDA also authorized marketing of a molecular-based assay to detect colonization with Candida auris, among other recent actions.
https://acphospitalist.acponline.org/archives/2024/08/28/updated-covid-19-vaccines-approved.htm
28 Aug 2024
Point-of-care HCV test, Alzheimer's drug approved
The newly approved test detects hepatitis C virus (HCV) RNA and delivers results in about an hour using a blood sample from the fingertip.
https://acphospitalist.acponline.org/archives/2024/07/31/point-of-care-hcv-test-alzheimers-drug-approved.htm
31 Jul 2024
RSV vaccine news, Entresto generic approval
The respiratory syncytial virus (RSV) vaccine by Moderna was newly approved for patients ages 60 years and older, while approval of the GlaxoSmithKline vaccine was expanded to ages 50 to 59 years, among other recent actions by the FDA.
https://acphospitalist.acponline.org/archives/2024/06/19/second-rsv-vaccine-first-entresto-generic-approved.htm
19 Jun 2024
New sepsis risk calculator that uses AI approved
The FDA approved an artificial intelligence (AI) program that identifies patients at risk for sepsis and a higher-dose naloxone spray, among other actions.
https://acphospitalist.acponline.org/archives/2024/05/15/new-sepsis-risk-calculator-that-uses-ai-approved.htm
15 May 2024
Antibiotic OKed for pneumonia, bloodstream, skin infections
In addition to approving ceftobiprole medocaril sodium for three different types of infection, the FDA authorized the first generic version of fidaxomicin, among other actions.
https://acphospitalist.acponline.org/archives/2024/04/10/antibiotic-oked-for-pneumonia-bloodstream-skin-infections.htm
10 Apr 2024
First medication for severe frostbite approved
The FDA also warned about smartwatches claiming to measure blood sugar without piercing the skin, among other recent actions.
https://acphospitalist.acponline.org/archives/2024/03/06/first-medication-for-severe-frostbite-approved.htm
6 Mar 2024
Genetic test for opioid disorder risk approved
The new test is to be used prior to patients' first exposure to oral opioids for the treatment of acute pain. Other recent FDA actions include a recall of overly potent IV drugs.
https://acphospitalist.acponline.org/archives/2024/02/07/genetic-test-for-opioid-disorder-risk-approved.htm
7 Feb 2024
New sickle cell therapies approved
The FDA also warned about eye infections with over-the-counter drops and skin reactions to antiseizure medications, among other actions.
https://acphospitalist.acponline.org/archives/2024/01/03/new-sickle-cell-therapies-approved.htm
3 Jan 2024
Surgical devices, ventilators, dialysis machines recalled
The FDA also approved first-time generics for spironolactone oral suspension and calcium gluconate, among other actions.
https://acphospitalist.acponline.org/archives/2023/11/15/surgical-devices-ventilators-dialysis-machines-recalled.htm
15 Nov 2023
New COVID-19 boosters, biosimilar for MS OK’ed
The FDA approved updated COVID-19 vaccines and the first-ever biosimilar for multiple sclerosis (MS), among other recent actions.
https://acphospitalist.acponline.org/archives/2023/10/04/new-covid-19-boosters-biosimilar-for-ms-oked.htm
4 Oct 2023
FDA provides info on stimulant shortage
Also, a sterilizer for 3D-printed medical devices, a drug for postpartum depression, and an RSV vaccine for pregnant patients were approved, among other recent FDA actions.
https://acphospitalist.acponline.org/archives/2023/08/30/fda-provides-info-on-stimulant-shortage.htm
30 Aug 2023
Catheters recalled; warning on troponin tests
The FDA announced a recall of certain peripheral catheters due to leaking and warned not to use a cardiac testing panel providing inaccurate troponin measurements, among other recent actions.
https://acphospitalist.acponline.org/archives/2023/08/02/catheters-recalled-warning-on-troponin-tests.htm
2 Aug 2023
New antibiotic approved for hospital-acquired pneumonia
The FDA approved sulbactam and durlobactam for injection to treat hospital-acquired or ventilator-associated pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex, among other recent actions.
https://acphospitalist.acponline.org/archives/2023/07/05/new-antibiotic-approved-for-hospital-acquired-pneumonia.htm
5 Jul 2023