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Food and Drug Administration (FDA)

Commissioner of the US Food and Drug Administration (FDA), Dr Scott Gottlieb, has released a statement highlighting new efforts to raise awareness of situations where drug makers may be ‘pursuing gaming tactics to delay generic competition’ more

News

A novel treatment for the prevention of migraines, Aimovig (erenumab-aooe), has received approval from the US Food and Drug Administration (FDA). more

News

The ISCT International Society Cell and Gene Therapy has announced its support of the US Food and Drug Administration’s request for injunctions against two US stem cell clinics that have administered unproven cellular therapy treatments to patients. more

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The ability of animal studies to predict human safety has been evaluated by global information analytics business, Elsevier, through big data analysis of adverse events reported to the US FDA and EMA more

Analysis

Orchard Therapeutics, a commercial stage company, has been granted a Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for its gene therapy candidate, OTL-200, for the treatment of patients with MLD more

News

A treatment for relapsing multiple sclerosis (Gilenya — fingolimod) has been approved for use in children and adolescents aged 10 years and older by the US Food and Drug Administration (FDA). more

News

Biosimilar entry onto US market is slow despite implementation of the Biologics Price Competition and Innovation Act (BPCIA) by the Food and Drug Administration (FDA), according to data and analytics company, GlobalData. more

Analysis

The FDA has filed two complaints in federal in court, in which it is seeking permanent injunctions against two stem cell clinics to prevent them from marketing stem cell products without FDA approval and for cGMP deviations more

News

Biotechnology company, Genmab, has announced that the FDA has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnos more

News

Two drugs, to be administered together for the treatment of ATC that cannot be surgically removed or has spread and has a type of abnormal gene, BRAF V600E, Tafinlar (dabrafenib) and Mekinist (trametinib), have been approved by the FDA more

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STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec has announced that its active pharmaceutical ingredient (API) R&D and manufacturing facility in Changzhou, China, has passed its first inspection by the US Food and Drug Administration (FDA). more

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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. more

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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. more

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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. more

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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)... more

News

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. more

Analysis

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 more

Opinion

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. more

Opinion

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. more

Technology

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) more

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