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Alphabet's Verily ECG watch gets FDA approval as medical device

ALPHABET'S VERILY ECG WATCH GETS FDA APPROVAL AS MEDICAL DEVICE

Alphabet unveiled Verily Study Watch in 2017, describing it as a smartwatch designed specifically for capturing health data from clinical...

Alphabet's health division gets FDA clearance to test EKG smartwatch feature

ALPHABET'S HEALTH DIVISION GETS FDA CLEARANCE TO TEST EKG SMARTWATCH FEATURE

Alphabet's health division, Verily, has received FDA 510 clearance for its Study smart watch for an “on-demand ECG feature.” The Study...

 
 
 
Failed Clinical Trial Puts Eli Lilly Cancer Drug in Limbo

FAILED CLINICAL TRIAL PUTS ELI LILLY CANCER DRUG IN LIMBO

An Eli Lilly drug on the market for a rare form of cancer is now in limbo, after it failed a trial needed to retain the FDA approval...

 
 
 
U.S. representative, advocates say food safety programs dangerously disrupted

U.S. REPRESENTATIVE, ADVOCATES SAY FOOD SAFETY PROGRAMS DANGEROUSLY DISRUPTED

The head of the Food and Drug Administration has taken some good steps toward restoring food safety inspections as the partial government...

FDA Panel Backs Amgen Bone Drug, Says Benefits Outweigh Heart Risks

FDA PANEL BACKS AMGEN BONE DRUG, SAYS BENEFITS OUTWEIGH HEART RISKS

An experimental Amgen osteoporosis drug that had sparked concern about cardiovascular side effects has won the backing of an FDA advisory...

 
 
 
FDA resumes some high-risk food inspections by calling in 150 unpaid workers

FDA RESUMES SOME HIGH-RISK FOOD INSPECTIONS BY CALLING IN 150 UNPAID WORKERS

The US Food and Drug Administration is calling about 150 unpaid employees back to wok in order to inspect domestic high risk food facilities...

FDA STARTS MORE UNPAID WORK AS SHUTDOWN ENTERS WEEK 4

The FDA has expanded the list of activities it expects staff to perform without being paid during the government shutdown. FDA Commissioner...

 
 
 
FDA's warning letters appear to drop off as budget/wall battle continues in D.C

FDA'S WARNING LETTERS APPEAR TO DROP OFF AS BUDGET/WALL BATTLE CONTINUES IN D.C

Pundits and politicians say there's no quick end in sight to the partial shutdown of the federal government as signs of the practical...

Stephen Colbert Finds Business Opportunities In Trump's Government Shutdown

STEPHEN COLBERT FINDS BUSINESS OPPORTUNITIES IN TRUMP'S GOVERNMENT SHUTDOWN

Here's what could happen now that the FDA has halted routine food inspections.

 
 
 
Notes from the JPM19 Vortex: Price Apocalypse, Celgene Fallout & More

NOTES FROM THE JPM19 VORTEX: PRICE APOCALYPSE, CELGENE FALLOUT & MORE

[ Editor's note: Ben Fidler and Sarah de Crescenzo coauthored this report .] It is here, and then it is gone. But by the time everyone...

FDA cancels two thirds of food safety inspections amid government shutdown

FDA CANCELS TWO THIRDS OF FOOD SAFETY INSPECTIONS AMID GOVERNMENT SHUTDOWN

The FDA will continue to inspect foreign and 'high risk' facilities that make things like eggs and fruits and vegetables in the US,...

 
 
 
Government Shutdown Stops Crucial FDA Food Safety Inspections

GOVERNMENT SHUTDOWN STOPS CRUCIAL FDA FOOD SAFETY INSPECTIONS

The FDA is struggling to perform crucial food safety duties amid the shutdown Nearly three weeks into the government shutdown created...

 
 
 
Publisher's Platform: I am Flying Wednesday, and you are Eating - Safely?

PUBLISHER'S PLATFORM: I AM FLYING WEDNESDAY, AND YOU ARE EATING - SAFELY?

Is the government shutdown compromising our safety? I have faith in the consummate professionalism of the 47,000 TSA inspectors as...

Bio Roundup: $74B for Celgene, Two CAR-T Tales, Ready for SF & More

BIO ROUNDUP: $74B FOR CELGENE, TWO CAR-T TALES, READY FOR SF & MORE

In 2018, my Exome colleagues and I published hundreds of stories about health, medicine, the biopharma industry, government policy,...

 
 
 

AT THE END OF A BUMPER YEAR FOR APPROVALS, FDA HIT BY GOVERNMENT SHUTDOWN

We saw a major milestone in FDA approvals in 2018, but a political deadlock that led to a partial government shutdown before Christmas...

 
 
 

FDA GRANTS PRIORITY REVIEW DESIGNATION FOR HERON THERAPEUTICS' NDA FOR HTX-011, A NON-OPIOID FOR POSTOPERATIVE PAIN MANAGEMENT

FDA Assigned PDUFA Goal Date of April 30, 2019 - FDA Not Currently Planning Advisory Committee Meeting for NDA - SAN DIEGO, Dec. 31,...

LARGE-SCALE MINING DISEASE COMORBIDITY RELATIONSHIPS FROM POST-MARKET DRUG ADVERSE EVENTS SURVEILLANCE DATA

Systems approaches in studying disease relationship have wide applications in biomedical discovery, such as disease mechanism understanding...