FDA Newswatch
FDA asks growers to report outbreaks
31 May 2020 05:39:03 UT
WASHINGTON — The Food and Drug Administration is asking farms and facilities it oversees for food safety to let the agency know if COVID-19 forced them to close temporarily or slow production. The...
U.S. FDA Red Flags Careful Cents, LLC for COVID-19 Claims
31 May 2020 00:57:56 UT
' Essential oils have many, many uses and a wide variety of treatments to help fight viruses,' Careful Cents, LLC, states on its website. 'You can use them for preventative care before getting sick...
FDA Recommends Voluntary Recall of Diabetes Drug After Tests Show Probable Carcinogen
30 May 2020 23:01:59 UT
Heavy/Wikimedia Commons Metformin The Food and Drug Administration announced that it has asked companies to voluntarily recall a diabetes drug because it could contain a probable carcinogen. The...
FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
30 May 2020 21:03:18 UT
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s...
Beware of food labels if you have allergies; FDA again relaxes rules due to COVID-19
30 May 2020 18:51:44 UT
FDA OKs Quest’s COVID-19 Self Collection Test Modern Healthcare
30 May 2020 17:37:47 UT
Quest Diagnostics said on Thursday that it has received Food and Drug Administration Emergency Use...
FDA Finds High Levels of Contaminant in Diabetes Drug
30 May 2020 16:14:01 UT
The FDA has found unacceptable levels of a cancer-causing ingredient in a diabetes drug and is asking 5 companies to issue a recall, according to the Wall Street Journal. I don't know about you,...
FDA Approves Cyramza-Tarceva Combination for Frontline Treatment of Patients With Metastatic EGFR-Mutated NSCLC
30 May 2020 15:53:38 UT
“The approval of this new firstline metastatic EGFR-mutated non-small cell lung cancer regimen … is an important milestone in the treatment of this disease,” said Dr. Edward Garon.   The Food and...
The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight
30 May 2020 14:30:42 UT
Benzinga – Stock Market News 0 Biotech stocks could not sustain the uptrend in the holiday-shortened week, even as traders digested COVID-19-related news flow, clinical readouts, ASCO presentations...
FDA Approves Immunotherapy Drug Combination for People With Most Common Type of Liver Cancer
30 May 2020 13:31:25 UT
The Jonsson Comprehensive Cancer Center at the University of California at Los Angeles issued the following news: For the first time in over a decade, a new drug combination has been approved by the...
FDA approves GE Healthcare's deep learning MR image reconstruction technology
30 May 2020 10:35:11 UT
The FDA has given GE Healthcare the green light to begin distributing its AIR Recon DL deep learning technology for MR image reconstruction. Developed on the company’s Edison Intelligence platform,...
FDA Oks Lilly's Drug To Image Tau Pathology In Patients Being Evaluated For Alzheimer's Disease
30 May 2020 09:50:35 UT
The U.S. Food and Drug Administration approved Tauvid for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer's disease in the brain called tau...
FDA Seeks Orange Book Feedback As Drug Guide Turns 40
30 May 2020 09:39:07 UT
With the 40th anniversary of the U.S. Food and Drug Administration's Orange Book just months away, the agency on Friday asked for feedback about how the drug guide can be improved and whether it...
FDA approves Roche immunotherapy cocktail in liver cancer
30 May 2020 09:13:31 UT
ZURICH (Reuters) – Swiss drugmaker Roche said on Friday that the U.S. Food and Drug Administration (FDA) approved its immunotherapy Tecentriq in combination with its drug Avastin for the...
Lilly's CYRAMZA® (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
30 May 2020 08:02:35 UT
CYRAMZA, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell lung cancer (NSCLC) with certain activating EGFR mutations, based on the...
FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer
30 May 2020 04:58:23 UT
SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )-- Genentech, Inc. a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has...
Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for RosaceaZILXI™ Now Approved for Inflammatory Lesions of Rosacea in Adults
30 May 2020 04:58:22 UT
(GLOBE NEWSWIRE) -- Menlo Therapeutics Inc   (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address...
FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women
30 May 2020 04:58:21 UT
  SILVER SPRING, Md. , May 29, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix,...
FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women
30 May 2020 03:38:27 UT
  NORTH CHICAGO, Ill. , May 29, 2020 /PRNewswire/ --  AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration...
FDA Approves Lilly's Cyramza To Treat Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
30 May 2020 03:37:42 UT
(RTTNews) - Eli Lilly and Co. (LLY) said that the U.S. Food and Drug Administration has approved Cyramza, in combination with erlotinib, for the first-line treatment of people with...

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