Lawmakers grill FDA commissioner over baby formula shortage
The Food and Drug Administration's commissioner is facing congressional lawmakers for the first time over the national shortage of baby formula (Source: ABC News: Health)
Source: ABC News: Health - May 19, 2022 Category: Consumer Health News Tags: Health Source Type: news

FDA clears modification for XACT's ablation steering system
The U.S. Food and Drug Administration (FDA) has cleared a modification for XACT'...Read more on AuntMinnie.comRelated Reading: XACT completes enrollment for clinical trial XACT hits procedure milestone with robotic interventional system Mass. hospital acquires XACT Robotics' system XACT Robotics' CT-guided system gets FDA nod XACT Robotics debuts robotic technology at RSNA 2019 (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - May 18, 2022 Category: Radiology Source Type: news

Since You ’re Already Getting a Flu Shot, Why Not One for Covid, Too?
Scientists and federal health officials are debating plans to pair coronavirus and flu vaccinations in the fall. (Source: NYT Health)
Source: NYT Health - May 18, 2022 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Coronavirus Omicron Variant Coronavirus (2019-nCoV) Vaccination and Immunization Centers for Disease Control and Prevention Food and Drug Administration United States Source Type: news

Increased Flexibility Seen in Preapproval Evidence for New Drugs
WEDNESDAY, May 18, 2022 -- The characteristics of acceptable preapproval evidence were more flexible for novel drugs approved by the U.S. Food and Drug Administration in 2020, according to a research letter published online May 17 in JAMA Network... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 18, 2022 Category: Pharmaceuticals Source Type: news

New Data Show TREMFYA ® (guselkumab) Binds to Both Inflammatory Cells and Interleukin (IL)-23, Supporting a Hypothesis for a Differentiated Mechanism from Risankizumab
SPRING HOUSE, PENNSYLVANIA, May 18, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the first results of the in vitro MODIF-Y studies, supporting a hypothesis that may differentiate the mechanism of first-in-class TREMFYA® (guselkumab) from risankizumab due to the ability of TREMFYA to bind to CD64 positive (CD64+) cells in addition to interleukin (IL)-23 — both of which are key components of the immune system. 1,2 These findings, which are being presented at the Society for Investigative Dermatology (SID) annual meeting May 18-21, 2022 in Portland, Oregon, demonstrate TREMFYA bind...
Source: Johnson and Johnson - May 18, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Judge signs off on steps troubled baby formula manufacturer must take to restart closed plant
A federal judge has signed off on a legally binding agreement between the United States Food and Drug Administration and the baby formula manufacturer Abbott Nutrition, the company at the heart of a nationwide formula recall. (Source: CNN.com - Health)
Source: CNN.com - Health - May 18, 2022 Category: Consumer Health News Source Type: news

FDA Expands Baby Formula Market to Foreign Suppliers
TUESDAY, May 17, 2022 -- Dealing with a crippling shortage of infant formula that has many U.S. parents desperate, the U.S. Food and Drug Administration on Monday announced " increased flexibilities " in allowing foreign manufacturers to help boost... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 17, 2022 Category: Pharmaceuticals Source Type: news

FDA Authorizes Pfizer Booster Shot for Children Ages 5 to 11 Years
TUESDAY, May 17, 2022 -- A single booster dose of the Pfizer COVID-19 vaccine can be given to 5- to 11-year-olds, the U.S. Food and Drug Administration announced today. The third shot can be given at least five months after healthy children... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 17, 2022 Category: Pharmaceuticals Source Type: news

FDA authorizes Pfizer Covid-19 booster shots for children ages 5 to 11
The US Food and Drug Administration has granted emergency use authorization for a booster dose of Pfizer/BioNTech's Covid-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series. (Source: CNN.com - Health)
Source: CNN.com - Health - May 17, 2022 Category: Consumer Health News Source Type: news

Abbott on a path to reopen factory to ease baby formula shortages
Abbott Laboratories has agreed to enter into a consent decree with the U.S. Food and Drug Administration (FDA) that would allow it to restart production of baby formula at its plant in Sturgis, Michigan, the company said Monday. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 17, 2022 Category: American Health Authors: Teddy Nykiel Source Type: news

U.S. FDA clears Pfizer's COVID booster shot for young children
The U.S. Food and Drug Administration has authorized the use of a booster shot of Pfizer and BioNTech's COVID-19 vaccine for children aged 5 to 11. (Source: CBC | Health)
Source: CBC | Health - May 17, 2022 Category: Consumer Health News Tags: News/Health Source Type: news

FDA authorizes single booster dose of COVID-19 vaccine for ages 5 through 11
The Food and Drug Administration on Tuesday authorized the use of a single booster dose of the COVID-19 vaccine produced by Pfizer-BioNTech for children ages 5 through 11. (Source: Health News - UPI.com)
Source: Health News - UPI.com - May 17, 2022 Category: Consumer Health News Source Type: news

FDA Clears COVID Booster Shot for Healthy Kids Ages 5 to 11
U.S. regulators on Tuesday authorized a COVID-19 booster shot for healthy 5- to 11-year-olds, hoping an extra vaccine dose will enhance their protection as infections once again creep upward. Everyone 12 and older already was supposed to get one booster dose for the best protection against the newest coronavirus variants—and some people, including those 50 and older, can choose a second booster. The Food and Drug Administration’s authorization now opens a third shot to elementary-age kids, too—at least five months after their last dose. There is one more hurdle: The Centers for Disease Control and Prevent...
Source: TIME: Health - May 17, 2022 Category: Consumer Health News Authors: LAURAN NEERGAARD / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

FDA authorizes COVID booster shot for healthy kids ages 5 to 11
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - May 17, 2022 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News COVID-19 Covid-19 Boston, MA Health Healthwatch Syndicated CBSN Boston Coronavirus Source Type: news

Supplements warning: FDA sends new alert over ingredient known to kill - ‘May be unsafe'
THE SUPPLEMENT industry has grown colossally, but questions raised over the safety of some pills could be tarnishing the market's reputation. In recent developments, the Food and Drug Administration has issued fresh warnings over one group of popular supplements, cautioning the pill could be ‘unsafe' for public consumers. (Source: Daily Express - Health)
Source: Daily Express - Health - May 17, 2022 Category: Consumer Health News Source Type: news