Search Results for “FDA” – Page 60 – media

FDA Anounces Restricted use of Keytruda & Tecentriq Against Bladder Cancer

Keytruda is now allowed only for the patients whose tumor expression levels of the biomarker PD-L1 meet a combined positive score of 10 or higher. Tecentriq can only be used where PD-L1 immune cells can cover only 5% or more of their tumor area.
- Source: FiercePharma
- 770
- June 26, 2018
bladder cancer Company Insights Merck Roche
Re-Investigation on FDA Approved Anti-Gout Drug Uloric

When the FDA approved this drug, there was an additional demand from the FDA to conduct post-marketing studies and assess the drug’s safety. Recently, a non-profit consumer advocacy group sent a petition requesting that the FDA should eliminate the drug from the U.S. pharma market since the drug shows significant risk of cardiovascular diseases.
- Source: FiercePharma
- 671
- June 25, 2018
cardiovascular disease Clinical Trials gout Takeda
Shortage in Drug Supplies, According to FDA

The U.S. healthcare system and the FDA have been affected by manufacturing issues at one of the largest U.S. drugmakers, Pfizer. The company’s Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
- Source: FiercePharma
- 789
- June 22, 2018
FDA Market Views Pfizer
FDA Approval for AI Enabled Diabetes Software

The Food and Drug Administration (FDA) has granted approval for a request made by DreaMed regarding their artificial intelligence-enabled diabetic software, which is exclusively meant for the providers, who are managing Type 1 diabetes patients.
- Source: MobiHealthNews
- 851
- June 20, 2018
AI digital health FDA New Approvals type 1 diabetes
FDA Gives OK for mHealth Wearable to Combat Opioid Addiction

DyAnsys’ Drug Relief, a wearable that is worn around the patient’s ear, is a neurostimulation therapy that helps to relieve the symptoms of opioid withdrawal such as depression, anxiety and cravings.
- Source: mHealth Intelligence
- 754
- June 15, 2018
FDA mHealth New Approvals opioid
FDA Considering Comments on SaMD Precertification Program

Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
- Source: Healthcare Info Security
- 723
- June 14, 2018
digital health FDA Market Views medical device
Mircera Gets FDA Nod For CKD-Related Drug

The recent research that achieved the FDA approval for Mircera, had 64 patients, aged between 5 to 17 years old who suffered from chronic kidney disease (CKD) and were on kidney dialysis at the beginning of the study.
- Source: MedPage Today
- 1,141
- June 13, 2018
chronic kidney disease New Approvals pharmaceutical
AbbvVie Under Fire From FDA Over Humira’s Death Complaints

Last year the FDA inspected the AbbVie North Chicago manufacturing site during which time they discovered that the company failed to do a proper investigation on five death complaints received relating to Humira and Venclexta treatments. Though the drug maker reported the deaths, it didn’t collate the historical data of the lots in question. It was later discovered that the lots were tied to another 8 to 10 deaths.
- Source: Fierce Pharma
- 613
- June 12, 2018
AbbVie Company Insight pharma
FDA Seeks Help From Social Media Giants To Help Stop Illegal Opioid Distribution

Scott Gottlieb, FDA Commissioner is looking for help from Facebook and Twitter to slow down the unauthorized opioid sales in the US. Gottlieb invited the two social media giants, among others, to participate in the FDA Online Opioid Summit which is set for June 27.
- Source: Fierce Pharma
- 567
- June 11, 2018
Company Insight digital health FDA opioid
FDA Recalls HeartMate device Manufactured by Abbott

This will be the second recall on a heart device this month Medtronic’s Heartware device and accessories was recalled a few days ago. This comes after Abbott issued a patch to negate cybersecurity issues 350,000 remote monitoring systems and pacemakers.
- Source: Ddu
- 703
- June 7, 2018
Abbott Company Insight heart failure medical device

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