Food and Drug Administration (FDA)

Biotechnology company, GamaMabs Pharma, has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead compound GM102 to treat advanced ovarian cancers.

The US Food and Drug Administration has approved a new treatment (Elreada) for patients with prostate cancer that is non-metastatic but continues to grow despite being treated with hormone therapy.

The US FDA has expanded its approval of Imfinzi (durvalumab) to now include the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumours are unresectable and have not progressed after chemoradiation treatment.

Clinical stage biotechnology company, Destiny Pharma, has announced that the US Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) for its lead clinical drug candidate, XF-73.

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) of Dupixent (dupilumab) for review, revealed joint developers of the drug, Regeneron and Sanofi.

At this year’s successful pharma packaging and drug delivery exhibition and conference, Pharmapack Europe, experts highlighted forthcoming major industry trends as being personalised medicines, intelligent packaging and US FDA deadlines

Data and analytics company, GlobalData, has revealed 2017 was a record-breaking year for the number of approvals of biosimilars.

The US Food and Drug Administration (FDA) has approved Addmedica’s drug Siklos (hydroxyurea tablets) for the treatment of paediatric patients, two years of age and older, suffering from sickle cell anaemia.

Commercial stage biotechnology acceleration development company, Q BioMed, and Bio-Nucleonics, licensor of Strontium-89 Chloride, have filed for regulatory approval of a new manufacturing facility by the US Food and Drug Administration (FDA).

The US FDA has approved Genetech’s Lucentis (ranibizumab injection) 0.3 mg prefilled syringe as a new administration method for the treatment of all forms of diabetic retinopathy (DR) in patients with diabetic macular oedema

The US Food and Drug Administration (FDA) has launched a mobile app to increase access to information about drugs, Drugs@FDA Express.

The US FDA has granted accelerated approval to Amgen’s Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukaemia who are in remission but still have minimal residual disease (MRD)

The US Food and Drug Administration (FDA) has granted orphan drug designation to Crossject's treatment for status epilepticus (epileptic seizure lasting longer than five minutes), ZENEO Midazolam.

Here, Dr Neil Polwart, Novarum founder and BBI group head of mobile, goes into greater detail about how digital technologies will herald a new era for pharma.

As pharma encounters massive shifts in public perception, which is seemingly negative in the current climate, Nick Johns from ConsumerSafety.org, looks at the focus of pharma in the US and how shifting this could benefit public perception

Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland.

The US Food and Drug Administration (FDA) has accepted priority review of the biologics licence application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)...

Swiss-based healthcare company, Novartis, has revealed that the US Food and Drug Administration (FDA) has approved its CAR-T therapy, Kymriah, for its second distinct indication.

The Janssen Pharmaceutical Companies of Johnson & Johnson, have announced the positive results from two Phase III clinical studies of esketamine nasal spray for the treatment of patients with treatment-resistant depression.

Swiss pharmaceutical group, Helsinn, has announced the launch of the intravenous formulation of AKYNZEO (a fixed combination of fosnetupitant, 235 mg, and palonosetron, 0.25 mg) in the US.

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