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Novel Agent Curbs Alzheimer's-Related Agitation

AXS-05, a combination of dextromethorphan and bupropion, led to a rapid and sustained improvement in agitation related to Alzheimer's disease in the phase 3 ACCORD trial.

Pennsylvania , United-states , Mansfield , New-york , University-of-rochester , American , Antonp-porsteinsson , Glenr-finney , Rebecca-edelmayer , Alzheimer-association , Drug-administration , American-academy-of-neurology

FDA Roundup: April 23, 2024

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a new...

Illinois , United-states , Missouri , Silver-spring , Brussels , Bruxelles-capitale , Belgium , American , Robertm-califf , European-union , Regulatory-agency

BEWARE: Hand Sanitizer Recalled In Texas Due To Lethal Ingredient

If you've recently purchased this hand sanitizer, you'll need to throw it out as soon as possible.

Aruba , United-states , Texas , Americans , Traci-taylor , Beth-mowbray , Estey-bomberger , Reesha-cosby , Us-food-and-drug-administration , Drug-administration , Aruba-aloe-hand-sanitizer-gel-alcohol

BEWARE: Hand Sanitizer Recalled In Texas Due To Lethal Ingredient

If you've recently purchased this hand sanitizer, you'll need to throw it out as soon as possible.

United-states , Aruba , Texas , Americans , Estey-bomberger , Traci-taylor , Beth-mowbray , Reesha-cosby , Us-food-and-drug-administration , Drug-administration , Aruba-aloe-hand-sanitizer-gel-alcohol

BEWARE: Hand Sanitizer Recalled In Texas Due To Lethal Ingredient

If you've recently purchased this hand sanitizer, you'll need to throw it out as soon as possible.

United-states , Aruba , Texas , Americans , Traci-taylor , Estey-bomberger , Beth-mowbray , Reesha-cosby , Us-food-and-drug-administration , Drug-administration , Aruba-aloe-hand-sanitizer-gel-alcohol

kilitch healthcare: USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant

The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for corrective action.

Mumbai , Maharashtra , India , Paresh-mehta , Drug-administration , Kilitch-healthcare-india , Managing-director-paresh-mehta , Kilitch-healthcare , Usfda , Cgmp , Us-food-and-drug-administration , Fda

FDA Expands Benralizumab Use for Asthma to Kids Over Age 6

The maintenance treatment for severe asthma with an eosinophilic phenotype originally was approved for patients aged 12 years and older.

Astrazeneca , Drug-administration , Asthma , Sthmatic , Severe-asthma , Ncontrolled-asthma , Childhood-asthma , Severe-allergic-asthma , Ncontrolled-allergic-asthma , Children , Hild

Popular Bandage Brands Band-Aid, Walmart and CVS Test Positive For Toxic PFAS

A recent study has revealed concerning levels of toxic PFAS "forever chemicals" in many popular bandage brands in the US, sparking worries about the safety of these commonly used products.

Linda-birnbaum , Environmental-protection-agency , Drug-administration , More-health-news , Walmart , Patch-bamboo-bandages , Kids-with-coconut-oil , Tone-bandages , Health-news , Child-safety , Fda , Health

Natco Pharma news: Natco Pharma gets warning letter from USFDA for Telangana plant

Natco Pharma, a pharmaceutical company, received a warning letter from the USFDA regarding its manufacturing plant in Telangana. This came after the FDA conducted an inspection of the company's facility in Kothur last October, issuing eight observations under Form 483.

Telangana , Andhra-pradesh , India , Kothur , Karnataka , Natco-pharma , Drug-administration , Natco-pharma-news , Usfda , Us-food-and-drug-administration ,

FDA Announces Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

/PRNewswire/ -- Today, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS...

Pennsylvania , United-states , Murrysville , California , Silver-spring , Jeff-shuren , Carly-kempler-pflaum , Brian-boynton , Philips-respironics , Roy-jakobs , Philips-respironic , Philips-respironic-mt