Tags: FDA

FDA Approves Merck's Capvaxive Vaccine Designed to Prevent Pneumonia on Adults

FDA Approves Merck's Capvaxive Vaccine Designed to Prevent Pneumonia on Adults

The Food and Drug Administration approved Merck’s new vaccine, Capvaxive, which was designed to protect adults from a bacteria known as pneumococcus that could cause serious illnesses like pneumonia, but is yet to face the CDC’s scrutiny.


FDA Pauses BioNTech's Chinese-Licensed Cancer Drug Trial Over Safety Issues

The FDA has paused BioNTech's breast and lung cancer trial involving licensed treatment from Chinese biotech MediLink Therapeutics Ltd., citing safety concerns.

Neuroelectrics Seeks FDA Approval for Non-Invasive Headcap for Epilepsy Treatment

Neuroelectrics seeks FDA approval for its noninvasive head cap that uses mild electrical currents to treat brain diseases, potentially transforming care for epilepsy, depression, and Alzheimer’s.

FDA Took Over a Year to Act on Whistleblower Tip About Abbott Nutrition, New Audit Finds

An audit revealed that the FDA took over 15 months to act on a whistleblower complaint about conditions at an Abbott Nutrition factory.


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Abbott Laboratories announced that new FDA-cleared continuous glucose monitor sensors are available over-the-counter without a prescription.
FDA Probes Diamond Shruumz Microdosing Chocolate Bars After 8 People Fall Sick
The FDA is examining Diamond Shruumz-brand microdosing chocolate bars after eight individuals experienced symptoms including vomiting, seizures, and central nervous system depression, prompting concerns over the product's safety.
Arexvy: GSK's RSV Vaccine Receives FDA Approval to Extend Its Use to High-Risk Adults in Their 50s
GSK has announced that the FDA has expanded the approval of its respiratory syncytial virus (RSV) vaccine, Arexvy, to those aged 50 to 59.
FDA Recalls Over 800,000 Units of Schreiber Foods’ Cream Cheese Products Over Salmonella Risk
The Food and Drug Administration issued a recall to over 800,000 cream cheese items from the Wisconsin-based Schreiber Foods after the company found that it might contain traces of salmonella in them.
FDA Recall Notice: Fresh Start Produce Sales Recalls Cucumbers Contaminated With Salmonella
FDA posted a recall notice confirming the mass recall of Fresh Start Produce Sales cucumbers, which could be contaminated with salmonella.
Obesity Drug Wegovy Reduces Risk of Heart Attack, Stroke, Despite Not Contributing Much to Patient’s Weight Loss, Study Finds
Telehealth startup Ro has launched a free online tracker to help patients and doctors locate in-stock weight-loss drugs like Wegovy amid national shortages, providing real-time availability and the option to report outages to the FDA.
Palmer Candy Recalls Over a Dozen 'White Coated' Confectionary Products Over Possible Salmonella Contamination
Palmer Candy, an Iowa-based candy company, is recalling several white-coated confectionary products due to potential Salmonella contamination.
The FDA's authorization of Prenosis' AI-powered sepsis diagnostic software offers a promising solution in identifying sepsis early, potentially saving lives amidst the condition's high mortality rates.
Merck has received approval from the Food and Drug Administration (FDA) for its new drug, Winrevair, designed to treat a rare and deadly lung condition.
The US Food and Drug Administration (FDA) has approved Madrigal Pharmaceuticals' Rezdiffra, the first drug to treat serious liver disease.
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