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Hurricane Ian eyes East Coast; warships on Korean coast; ALS drug approved

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On Sept. 30, 2022, Hurricane Ian is projected to make its second landfall in the U.S.; a set of warships belonging to the U.S., Japan and South Korea set sail in the face of heightened threats from North Korea; and a new drug to treat ALS has received FDA approval.

Hurricane Ian heads toward Carolinas – After briefly dropping to a tropical storm on Thursday, Hurricane Ian has gained momentum as it heads for the Carolinas today. The entirety of the South Carolina coast is under a hurricane warning while officials are forecasting a life-threatening storm surge. Twelve deaths have been linked to the hurricane as of Friday morning.

U.S., Japan, South Korea warships sail – American, Japanese and South Korean warships gathered around the Korean peninsula Friday. The three nations are conducting their first trilateral anti-submarine drills in five years. The drills can be seen as a response to North Korea, which has tested several sophisticated missiles meant to be fired from submarines.

New ALS treatment receives FDA approval – The FDA has approved the drug Relyvrio to treat ALS, commonly known as Lou Gehrig’s Disease. Relyvrio is now the third U.S. approved medicine for ALS. FDA approval didn’t come without controversy. It was based on results from a single study. Typically, the FDA requires two large studies or one study with “very persuasive” results according to FDA scientists. The FDA has acknowledged the study has its limitations but said the approval was necessary as treatments for ALS are few and far between.

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AFTER BRIEFLY DROPPING TO A TROPICAL STORM YESTERDAY — HURRICANE IAN HAS GAINED MOMENTUM AS IT HEADS FOR THE CAROLINAS TODAY.
THE ENTIRETY OF THE SOUTH CAROLINA COAST IS UNDER A HURRICANE WARNING — OFFICIALS ARE FORECASTING A LIFE THREATENING STORM SURGE. 12 DEATHS HAVE BEEN LINKED TO HURRICANE IAN.
AMERICAN — JAPANESE — AND SOUTH KOREAN WARSHIPS TOOK TO THE SEAS TODAY.
THE THREE NATIONS — CONDUCTING THEIR FIRST TRI-LATERAL ANTI-SUBMARINE DRILLS IN FIVE YEARS.
THE DRILLS CAN BE SEEN AS A RESPONSE TO NORTH KOREA — WHO HAS BEEN TESTING SOPHISTICATED MISSILES THAT CAN BE FIRED FROM THEIR NEWLY BUILT SUBMARINES.
THE F-D-A HAS APPROVED THE DRUG RELYVRIO TO TREAT A-L-S — COMMONLY KNOWN AS LOU GEHRIG’S DISEASE.
RELYVRIO IS NOW THE THIRD U-S APPROVED MEDICINE FOR A-L-S.
HOWEVER F-D-A APPROVAL DIDN’T COME WITHOUT CONTROVERSY.
IT WAS BASED ON RESULTS FROM A SINGLE STUDY.
TYPICALLY — THE F-D-A REQUIRES TWO LARGE STUDIES — OR ONE STUDY WITH “VERY PERSUASIVE” RESULTS.
THE FDA HAS ACKNOWLEDGED THE STUDY HAS ITS LIMITATIONS.
BUT SAY THE APPROVAL WAS NECESSARY AS TREATMEANTS FOR A-L-S ARE FEW AND FAR BETWEEN.