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FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections
(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical...
US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney Disease
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin)...
About 1 in 14 U.S. Adults Have Had Long COVID
One in every 14 American adults has suffered from long COVID, a new federal survey has found. About 7% of adults have ever had long COVID and more than...
Strike a Pose: Yoga Helps Heart Failure Patients
Heart failure can make everyday activities and exercise tough to carry out, but yoga might be a beneficial add-on to standard care. A new study from India...
Stigma, Even Harm Common When Transgender People Meet With Doctors
Transgender people have a tough time receiving adequate medical care due to issues like voyeurism, being treated as abnormal and even being denied care...
Buying Marijuana Online Easy for Minors, Study Finds
TUESDAY, Sept. 26, 2023 – The lax enforcement of age limits by many online marijuana dispensaries makes it easier for minors to buy weed, claims new...
NMD Pharma initiates Phase II trial of NMD670 in Spinal Muscular Atrophy
Aarhus, Denmark, 26 September 2023 – NMD Pharma A/S, a clinical-stage biotech company developing first-in-class, small molecule ClC-1 inhibitors...
Reviva Announces Last Patient Evaluated in Pivotal Phase 3 RECOVER Trial for Brilaroxazine in Schizophrenia
CUPERTINO, Calif., Sept. 25, 2023. Reviva Pharmaceuticals Holdings, Inc. (“Reviva” or the “Company”), a late-stage pharmaceutical...
Gene-Tweaked Pig Heart Transplant Into Second Patient
A second human patient has received a genetically altered pig heart as he battles the ravages of end-stage heart disease. The 58-year-old man, Lawrence...
37 Percent Diagnosed With Type 1 Diabetes After Age 30
Diagnosis of type 1 diabetes often occurs after age 30 years, more so in men and racial/ethnic minorities, according to a research letter published online...
Heat-Related Deaths Could Break Records This Year in Phoenix, America's Hottest City
Phoenix, already the hottest major city in the nation, experienced its most scorching summer on record this year, new data show. And that will likely prompt...
Family History Influences Penetrance of Hereditary Cancers
For individuals with a pathogenic variant in the major genes responsible for hereditary breast cancer or Lynch syndrome, having a first-degree family history...
FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label
Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s...
VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer...
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...
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...
Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 20, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration...
UCB Provides Update on U.S. Regulatory Review of Bimekizumab
Brussels (Belgium), 19 September 2023 – UCB, a global biopharmaceutical company, today provided an update on the Biologics License Application (BLA)...
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...
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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
- Likmez Likmez (metronidazole) is an oral liquid suspension formulation of the approved antibiotic metronidazole for the treatment of parasitic and...
- 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...
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.
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