New drug for treatment-resistant forms of tuberculosis approved
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
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Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
The US supply of heparin, an ingredient used in anticoagulant drugs and found in pigs, is under threat due to an outbreak of disease in Chinese herds.
A three-drug combination injection to treat patients with complicated urinary tract and intra-abdominal infections has been approved by the FDA.
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
The US Food and Drug Administration has posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (cGMP) regulations...
A New Drug Application has been made to the US Food and Drug Administration for the drug darolutamide to treat non-metastatic prostate cancer...