Diseases and Drugs


collage-dec31.jpg A total of 48 novel drugs and biologics received FDA approval in 2019. Let's take a look at the FDA calendar of January 2020.

failure-dec17.jpg In this article, we present some of the phase III clinical trial failures that made major news headlines in 2019. These were compounds on which companies had bet big, with patients and the medical community having had high hopes.

sentosa-dec02.jpg As we begin the final month of the year, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision.

stickfigures-nov20.jpg It's been more than 4 years since the first biosimilar Zarxio was approved in the U.S. Zarxio, developed by Sandoz, a Novartis division, is a biosimilar version of Amgen Inc.'s (AMGN) Neupogen, and it received the regulatory nod in the U.S. in March 2015.

trikafta-oct28.jpg As another month comes to an end, 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.

fdaapproval-oct04.jpg New drugs approved in September

rybelsus-sept27.jpg It has been an eventful September, with a number of notable firsts achieved on the regulatory front. Now, let's take a look at the companies that await a ruling from the FDA in October 2019.

lightwaves-090419.jpg A first-in-human trial, which evaluated Nanospectra Biosciences' investigational device AuroLase in men with low-to-intermediate grade tumors within the prostate, has yielded positive results.

turalio-aug26.jpg The month of August saw some important decisions and a couple of firsts happening on the regulatory front. Let's take a look at what's in store for the month of September.

fdaapproval-march25.jpg A first of its kind device to treat pediatric patients with progressive idiopathic scoliosis has won the FDA nod. The device, called The Tether - Vertebral Body Tethering System, developed by Zimmer Biomet Holdings, Inc. (ZBH), is intended to be used in children and adolescents to correct idiopathic scoliosis that has not responded to external bracing.

lyrica-july29.jpg After having had a banner year for new drug approvals in 2018, hitting a record number of 59, it looks like the pace of FDA approval is slowing down this year. Only 16 new drugs have been greenlighted so far this year compared to 26 during the same period last year. Let's take a look at the companies that await a ruling from the FDA in August 2019.

opioids-july23.jpg The opioid crisis in the United States has grown at an alarming rate. It is estimated that more than 300,000 Americans have died of an opioid overdose since 2000. Among the American states, Alabama has the highest rate of opioid prescriptions - with healthcare providers writing 107.2 opioid prescriptions for every 100 persons. West Virginia has the highest rate of death due to drug overdose.

fdaapproval-march25.jpg On July 1 of this year, the regulator eliminated the REMS for Truvada and its generics. According to FDA, now, after seven years, vast majority of health care professionals and at-risk individuals are aware of the risks and prevention methods of HIV infection, and educational materials and treatment guidelines are readily available at the U.S. Centers for Disease Control and Prevention.

emgality-jun26.jpg So far this year, i.e, January to June, only 12 novel drugs have been approved compared to 20 during the same period last year. Now, let's take a look at the biotech stocks awaiting the U.S. regulatory decision in July.

beware-jun12.jpg Everyone dreads catching a viral infection. The word "virus" has its origin in Latin, which means slimy liquid or poison, and it has been associated with a number of disease outbreaks, epidemic, and pandemic. Now, let's take a look at some of the viruses that are posing a constant threat to mankind.

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