Food And Drug Administration

Tubeless Insulin Pump Works; Insulin Pens Vs Syringes; Caffeine And Osteoporosis

(MedPage Today) -- A tubeless, patch-pump automated insulin-delivery system -- Insulet's Omnipod 5 -- was both safe and effective in a prospective study of kids and adults with type 1 diabetes. Following a positive meeting with the FDA, Radius...
Related topics: Insulin, Caffeine, Osteoporosis, Medical Research, Type 1 Diabetes, Diabetes

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Should Medicare Pay For Aduhelm?

In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer’s disease using the agency’s accelerated approval pathway, despite significant concerns about the evidence regarding the drug’s safety and...
Related topics: Medicare, Alzheimer's Disease

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Iv Antibiotic Approved For Kids With Skin Infections

(MedPage Today) -- Antibiotic dalbavancin (Dalvance), previously approved to treat bacterial skin infections in adults, received FDA approval for the pediatric population from birth, manufacturer AbbVie said in a press release on...
Related topics: Antibiotics, Bacteria

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Fda Must Act Quickly On Menthol Ban To Save Black Lives, Advocates Argue

(MedPage Today) -- Tobacco control advocates argued that the FDA must act swiftly to ban all menthol products and address the "pernicious targeting" of Black smokers, during an online briefing hosted by the Alliance for Health Policy and sponsored...
Related topics: Smoking

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Slow Going With Car T-cell Therapy For Solid Tumors

(MedPage Today) -- Almost 4 years after the first chimeric antigen receptor (CAR) T-cell therapies received FDA approval, the transformative impact of the treatment on refractory hematologic malignancies has yet to translate into the field of...
Related topics: Cancer

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Exenatide Ok'd For Type 2 Diabetes In Adolescents

(MedPage Today) -- Once-weekly exenatide extended-release (Bydureon BCise) is now FDA approved for children with type 2 diabetes ages 10 and up, AstraZeneca announced. Already approved in adults, the expanded label now holds an indication for...
Related topics: Type 2 Diabetes, Diabetes, Astrazeneca

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Health Highlights: July 23, 2021

Here's some of HealthDay's top stories for Friday, July 23: Arguing for & against approval of controversial Alzheimer's drug. The FDA earlier this month gave its OK to the first new Alzheimer's drug in years -- despite its own panel voting...
Related topics: Alzheimer's Disease

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The Big Winner With Johnson & Johnson's Recent Fda Approval

Johnson & Johnson (NYSE: JNJ) already has a blockbuster winner with blood cancer drug Darzalex. The healthcare giant recently picked up a U.S. Food and Drug Administration (FDA) approval for a subcutaneous version of the drug that's more...
Related topics: Cancer, Oncology

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Biogen Defends Controversial Alzheimer's Drug As Fda Calls For Probe

For more crisp and insightful business and economic news, subscribe to The Daily Upside newsletter. It's completely free and we guarantee you'll learn something new every day.Biogen's new — and controversial — Alzheimer's drug, Adhulem,...
Related topics: Alzheimer's Disease

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To Pay Or Not To Pay: Medicare's Big Aduhelm Decision

(MedPage Today) -- In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer's disease using the agency's accelerated approval pathway, despite significant concerns about the evidence regarding the drug's safety and...
Related topics: Medicare, Alzheimer's Disease

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Muffins Recalled For Possible Listeria Contamination

THURSDAY, July 22, 2021 -- Possible Listeria contamination has triggered the nationwide recall of more than two dozen muffin products made by Give and Go Prepared Foods, the U.S. Food and Drug Administration said Wednesday. The recalled products...

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Fda's Device Center Needs More $$, Staff, Says Center Director

(MedPage Today) -- WASHINGTON -- The FDA's center for approving devices has neither the staff nor the money it needs to fully do its job, said Jeffrey Shuren, MD, JD, at a briefing sponsored by the Alliance for a Stronger FDA on Thursday. "Are...

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Pfizer (pfe) Inks Vaccine Deal, Faces Fda Delay On Jak Drugs

Pfizer PFE along with BioNTech BNTX announced that they have entered into a collaboration with South African biopharma company Biovac to manufacture and distribute their COVID-19 vaccine within Africa.Pfizer expects Biovac to initiate the...
Related topics: Pfizer, Vaccines, South Africa

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Study Of Cancer Patients And Covid-19 Highlights Health Disparities

Findings from a study led by researchers at Henry Ford Cancer Institute, in collaboration with Advocate Aurora Health, the Food and Drug Administration and Syapse(r), show an elevated risk for severe COVID-19 effects or death among patients with...
Related topics: Medical Research, Cancer, Oncology

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Drug Overdoses Spike; Shock Therapy Effective; Psychiatrist Charged For 'pill-mill'

(MedPage Today) -- The American Psychiatric Association issued a renewed call to action to combat the sharply increasing rates of drug overdose deaths. Lyndra Therapeutics got the green light from the FDA on the company's proposed pivotal trial...

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Do You Know The Muffin Ban? Recall Affects 26 Products Nationwide

The Food and Drug Administration (FDA) and Give & Go Prepared Foods Corp. on Monday announced a voluntary recall of 26 muffin and muffin-related products available nationwide over concerns of possible listeria contamination....

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Fda Oks Spinal Cord Stimulation For Diabetic Neuropathy Pain

The approval is specific for the treatment of chronic pain associated with painful diabetic neuropathy in those whose pain is refractory or who can't tolerate medical treatment. FDA Approvals
Related topics: Diabetes, Chronic Pain

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Abbvie (abbv) Venclexta Gets Breakthrough Therapy Tag For Mds

AbbVie Inc. ABBV announced that the FDA has granted a Breakthrough Therapy designation to Venclexta (venetoclax) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very...

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Nevro's (nvro) Senza System Approved By Fda For Pdn Treatment

Nevro Corp. NVRO recently announced the receipt of the FDA’s approval for its Senza System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (“PDN”). The approval is, however, specific to Nevro's...
Related topics: Chronic Pain, Diabetes

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Albireo (albo) Gets Fda Nod For Rare Liver Disease Drug

Albireo ALBO announced that the FDA has approved Bylvay (odevixibat) to treat intense itching or pruritus in progressive familial intrahepatic cholestasis (“PFIC”).PFIC, a rare disorder, is a type of cholestasis or impaired bile flow...
Related topics: Liver Disease

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