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FDA Approves Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia
Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated...
FDA Approves New and Updated Indications for Temozolomide Under Project Renewal
On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology...
Babies May Leave Cells Behind That Help Mom Prepare for Future Pregnancies
One pregnancy may leave behind microscopic souvenirs that prepare a mom's immune system for the next one, a new study suggests. Experts said the research,...
Higher Buprenorphine Dose Increases Likelihood of Staying in Treatment
Patients initiating buprenorphine treatment for opioid use disorder who are prescribed a 24-mg dose are more likely to remain in treatment longer than...
Treatment Failure Similar for Amoxicillin +/− Clavulanate for Pediatric Acute Sinusitis
There is no difference in the risk for treatment failure for outpatient children with acute sinusitis treated with amoxicillin-clavulanate compared with...
Dabrafenib, Trametinib Active in Pediatric Glioma With BRAF V600
Dabrafenib plus trametinib results in significantly more responses and longer progression-free survival than standard chemotherapy for pediatric patients...
Today's COVID Is Increasingly Looking Like a Cold or Flu
Symptoms of mild COVID-19 infection have shifted this season, and now are more akin to those of allergies and the common cold, doctors say. Many people...
Fluticasone Furoate Does Not Cut Time to COVID-19 Symptom Resolution
For outpatients with mild-to-moderate COVID-19, inhaled fluticasone furoate does not shorten time to symptom resolution, according to a study published...
FDA Must Crack Down on Retailers Selling Tobacco to Teens: Report
A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco. Among the report’s...
Suppressing Negative Thoughts Can Sometimes Be Healthy, Study Contends
A longstanding core belief of mental health maintains that people must confront their fears to ease the anxiety and depression stemming from those negative...
Leucid Bio Granted MHRA Clinical Trial Authorisation for Lateral NKG2D CAR-T Cell Therapy LEU011
LONDON, Sept. 21, 2023 . Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company pursuing the development of innovative Chimeric...
Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive Disorder
CORAL GABLES, Fla., Sept. 20, 2023, Relmada Therapeutics, Inc., a late-stage biotechnology company addressing diseases of the central nervous system (CNS),...
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile. The FDA has identified this as...
FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced...
Using Meds to Manage Your Arthritis Pain: An Overview
Millions of Americans suffer from arthritis, and many reach for medication to ease their joint pain and inflammation. The options might seem overwhelming,...
FDA is Changing the Therapeutic Equivalence Rating for Accord Healthcare Inc.’s Generics of Prograf (tacrolimus) Oral Capsules
Based on new data, the U.S. Food and Drug Administration is changing the therapeutic equivalence rating for tacrolimus oral capsule products manufactured...
Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated...
Recently Added
Recently added consumer and prescribing information: Ojjaara, Tyruko, Bylvay, Xdemvy, Cyfendus, Ycanth, Beyfortus, Roctavian, Lantidra, Ngenla
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Latest FDA New Drug Approvals
- Ojjaara Ojjaara (momelotinib) is a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor for the treatment of myelofibrosis patients with anemia.
- Aphexda Aphexda (motixafortide) is a hematopoietic stem cell mobilizer indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic...
- Tyruko Tyruko (natalizumab-sztn) is an integrin receptor antagonist biosimilar to Tysabri, approved for the treatment of multiple sclerosis and...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...
- Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.