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Diseases and Drugs

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spectrum-feb12.jpg Non-alcoholic steatohepatitis, or NASH, which refers to liver inflammation due to fat buildup in the liver, is said to affect an estimated 16 million Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD. The incidence of NASH is on the rise, and even worrying is the fact that there are no approved treatments for the disease, yet.

february-fda-012419.jpg 2018 was a banner year not just for novel drug approvals but for novel device approvals as well. Last year, 59 novel drugs and 106 novel devices were greenlighted by the regulatory agency compared to 46 novel drugs and 99 novel devices approved in 2017. Now, let's take a look at the biotech stocks that await a ruling from the FDA in February 2019.

cancer-011819.jpg Cancer is the second leading cause of death in the world, next to heart disease. Let's take a look at some of the companies whose cancer drugs are in phase III /pivotal trials.

fdaapproved-jan15.jpg 2018 marked a record year for new drug approvals, with 59 new molecular entities, or NMEs, getting the FDA's stamp of approval. The only other time the number of new drug approvals crossed 50 was in 1996 when the tally was 53.

genetherapy-jan10.jpg The concept of gene therapy, which originated in the late 1960s, has come a long way - having had its own share of significant setbacks and gargantuan success. Now, let's take a look at some of the companies developing gene therapies, and the latest update on their pipeline.

dna-dec31.jpg After decades of research and development in RNA interference (RNAi), considered one of the most exciting discoveries in biology, the year 2018 saw the first-ever RNAi drug pass regulatory muster in the United States. Let's take a look at some of the biotechnology companies developing RNA-based therapeutics.

fda-dec24.jpg As 2018 fades, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision in January 2019.

eshowdecemberprimatene-dec17.jpg After 7 years of absence, asthma inhaler Primatene Mist, developed by Amphastar Pharmaceuticals, is reentering the market with renewed features.

fda-nov26.jpg With already 51 new molecular entities, or NMEs, getting greenlighted by the FDA so far this year, and still 1 more month to go, 2018 could be a banner year. This outpaces the 53 new drugs approved in 1996 - the highest ever.

fda-oct29.jpg As another month comes to a close, it's time to take a look back at some of the pharma news stories of October, and look ahead at what's coming next over the horizon on the regulatory front.

octobercalendar-sept28.jpg As we head into another month of new drug approvals, it's time to take a look at some of the FDA-related news that grabbed headlines in September. Seeking to curb the sharp rise in the number of teens using e-cigarettes, the FDA, has expanded its Youth Tobacco Prevention Plan, which was first introduced last April.

calendar-sep-083018.jpg August proved to be a very busy month on the regulatory front, in terms of Novel Drug approvals, the ongoing efforts to restrict opioid abuse, and new efforts to encourage further advances in the rapidly evolving field of gene therapy. Now, let's take a look at the biotech stocks awaiting FDA decision in September.

fda-aug17.jpg In the month of July, 9 drugs were approved by the FDA, including novel drugs and biosimilars.

pharma-august-072518.jpg As another month comes to a close, it's time to take a look back at some of the biggest news stories of July on the pharma sector, and look ahead at what's coming next over the horizon on the regulatory front.

usfood-july16.jpg The process of drug development is challenging. Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval. As of this writing, 21 novel drugs have been approved by the FDA so far this year. Novel drugs are new molecular entities (NMEs) having...

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