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FDA grants Rozlytrek cancer treatment approval
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
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US Food and Drug Administration (FDA)
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Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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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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FDA to deactivate out-of-date drug listings in its database
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
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Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
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FDA grants Orphan Drug Designation to DYN101 treatment
A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.
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FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
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Novartis could face legal action over Zolgensma application
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
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Swine fever in China raises concern over heparin supply for US
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.
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US Food and Drug Administration approves Recarbrio
A three-drug combination injection to treat patients with complicated urinary tract and intra-abdominal infections has been approved by the FDA.
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EMA grants AR-501 with Orphan Drug Designation
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
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FDA approves treatment for refractory multiple myeloma
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
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FDA issues three warning letters to API re-packers
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
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First PI3K inhibitor for breast cancer approved by FDA
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
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Concerns around Annex 1
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.
