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Diseases and Drugs

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fdaapproval-march25.jpg On April 8, the FDA approved Dovato, a two-drug regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history.

anaptysbio-april12.jpg Peanut allergy, a condition in which the immune system mistakenly recognizes a number of proteins from peanuts as potential foreign pathogens, triggering an inflammation, is most common in children. The rate of peanut allergy is on the rise - with approximately 2 percent of children, roughly 1.5 million children in the U.S., being affected, according to the Jaffe Food Allergy Institute.

customersurprised-april03.jpg It typically takes 10-12 years to introduce a new drug into the market - i.e., from the initial discovery stage to regulatory approval - and it costs the drugmakers an average of $2.6 billion.

fda-march26.jpg So far this year, 4 novel drugs have been approved in the U.S., including Zulresso. Now, let's take a look at the companies that await a ruling from the FDA in April 2019.

fdaapproval-march25.jpg Postpartum depression, or PPD, is a mood disorder that can affect women after childbirth. In the U.s., estimates of new mothers identified with PPD each year vary by state from eitht to 20/%, with an overall average of 11.5%.

alzheimer-march01.jpg Alzheimer's is the 6th leading cause of death in the U.S., and there is no cure yet for this neurodegenerative disease. The available medications for Alzheimer's can only alleviate symptoms temporarily, and they don't work for everyone.

fda-feb26.jpg After a banner year in 2018, the novel drug approval is off to an uncharacteristically slow start this year. No novel drug was approved in January while three were approved in February.

pharma-oct17.jpg In January, the FDA approved two drugs. One is a biosimilar for the treatment of breast cancer and the other is a nasal spray for migraine.

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.

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