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Food and Drug Administration (FDA)

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

8 Dec 2017 15:00 News

Genoscience Pharma has announced that initiation of a Phase Ib/IIa study of its most advanced compound, GNS561, for the treatment of patients with advanced hepatocarcinoma (HCC), has received approval from the US Food and Drug Administration (FDA). more

8 Dec 2017 12:00 News

The US Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of certain breast and stomach cancers, Ogivri (trastuzumab-dkst). more

5 Dec 2017 14:49 News

Today (Monday 27 November) marks the original deadline date for the DSCSA. While the FDA has delayed its enforcement of compliance with these serialisation requirements by a year, pharma is still required to legally comply. Industry tells us more… more

27 Nov 2017 12:40 Opinion

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

24 Nov 2017 15:17 News

The US Food and Drug Administration (FDA) has approved the first two-drug regimen for certain patients with human immunodeficiency virus type 1 (HIV-1). more

23 Nov 2017 14:20 News

Genmab’s licensing partner, Janssen Biotech, has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in front line multiple myeloma. more

22 Nov 2017 14:10 Technology

The International Society for Cellular Therapy (ISCT) has stated its support of the US Food and Drug Administration’s (FDA’s) new comprehensive Regenerative Medicine Policy Framework. more

21 Nov 2017 14:21 News

The US Food and Drug Administration (FDA) has approved Sutent (sunitinib malate) for the adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy. more

20 Nov 2017 14:45 News

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

17 Nov 2017 14:39 News

The US Food and Drug Administration (FDA) has granted marketing authorisation to an electric stimulation device aimed at helping to reduce the symptoms associated with opioid withdrawal. more

16 Nov 2017 12:35 Technology

Decision support technology and consulting organisation, Certara, has revealed that the US FDA has renewed and expanded its use of the company’s PBPK Simcyp population-based simulator and its paediatric and cardiac safety simulators. more

15 Nov 2017 14:13 Technology

The US Food and Drug Administration (FDA) has approved a drug with an ingestible sensor embedded in it that can record if the medication is ingested or not. more

14 Nov 2017 14:40 Technology

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

10 Nov 2017 15:30 News

The US Food and Drug Administration (FDA) has granted fast track designation to Infirst Healthcare’s haemoglobin spray, Granulox, for the treatment of diabetic foot ulcers (DFUs). more

10 Nov 2017 09:00 News

As a part of its ongoing efforts to protect consumers, the US FDA has issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat or cure cancer without support evidence. more

7 Nov 2017 12:24 News

The advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of Braeburn Pharmaceutical’s investigational buprenorphine depot, CAM2038, for the treatment of opioid use disorder. more

7 Nov 2017 12:21 News

A new drug application (NDA) for VYZULTA — a prostaglandin analogue indicated for the reduction of intraocular pressure (IOP) — has been approved by the US Food and Drug Administration (FDA). more

6 Nov 2017 12:34 News

The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, for relapsed and refractory multiple myeloma more

6 Nov 2017 12:28 News

The US Food and Drug Administration (FDA) has accepted and granted priority review of a supplemental new drug application (sNDA) for Lynparza to be used in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer. more

19 Oct 2017 11:41 News