Drugs.com

DECEMBER 22, 2023

The FDA said Thursday that it has seized thousands of. FRIDAY, Dec. 22, 2023 -- The U.S. Food and Drug Administration has uncovered counterfeit Ozempic shots in the legitimate U.S. drug supply chain, and is warning patients to be on their guard.

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APRIL 1, 2024

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

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DECEMBER 8, 2023

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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OCTOBER 31, 2023

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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Drugs.com

JULY 29, 2024

late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S. Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In

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DECEMBER 19, 2024

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Drugs.com

JANUARY 31, 2025

Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin. FRIDAY, Jan. 31, 2025 -- The U.S. The new pill, developed by Vertex.

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Drugs.com

JANUARY 29, 2025

Food and Drug Administration (FDA) has officially approved Ozempic to. WEDNESDAY, Jan. 29, 2025 -- A popular diabetes drug just got a major new approval -- and it could be a game-changer for millions of Americans at risk for kidney failure.

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OCTOBER 23, 2023

since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S.

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APRIL 5, 2024

The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.

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Drugs.com

JULY 30, 2024

Food and Drug Administration warns.These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA. TUESDAY, July 30, 2024 -- People taking compounded versions of Ozempic have been overdosing on the drug, the U.S.

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JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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Drugs.com

DECEMBER 27, 2024

Food and Drug Administration (FDA) has proposed a new rule to require standardized testing of talc-containing cosmetics for asbestos, a known carcinogen linked to serious illnesses such as lung and ovarian. FRIDAY, Dec. 27, 2024 -- The U.S.

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Drugs.com

AUGUST 1, 2024

FDA is warning consumers not to purchase or use. THURSDAY, Aug. 1, 2024 -- Don't use a chemical peel to help rejuvenate your skin unless it's done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised.

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FEBRUARY 27, 2025

The meeting, which helps the FDA give guidance to vaccine makers on which flu strains to target, is the second to be disrupted since Robert F. Kennedy Jr. was sworn in as health secretary.

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NOVEMBER 29, 2023

Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.

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FEBRUARY 20, 2025

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

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Drugs.com

JANUARY 7, 2025

Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this week. TUESDAY, Jan. 7, 2025 -- The U.S. However, many health and safety advocates say they are not satisfied with the guidance.Under.

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Drugs.com

JANUARY 15, 2025

Food and Drug Administration (FDA) has proposed a new rule requiring bold, easy-to-read nutrition labels on the front of food and beverage. WEDNESDAY, Jan. 15, 2025 -- Grabbing a quick snack might soon come with a little extra clarity.

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JANUARY 24, 2025

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

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Drugs.com

JANUARY 16, 2025

Food and Drug Administration (FDA) proposal aims to make cigarettes and other tobacco products far less addictive by reducing their nicotine content.The move could help millions of Americans quit. THURSDAY, Jan. 16, 2025 -- A rather historic U.S.

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Drugs.com

JUNE 11, 2024

an advisory, the FDA told. TUESDAY, June 11, 2024 -- Seafood lovers should steer clear of shellfish from Oregon and Washington state because of possible contamination with a paralyzing toxin, the U.S. Food and Drug Administration has warned.In

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Drugs.com

SEPTEMBER 19, 2024

Food and Drug Administration warns.This inaccurate labeling could put people with milk allergies in danger, the FDA no. THURSDAY, Sept. 19, 2024 -- Consumers should be aware that some chocolate labeled as “dairy-free” actually contains milk, the U.S.

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Drugs.com

JANUARY 31, 2025

Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin.The new pill, developed by Vertex Pharmaceuticals. FRIDAY, Jan. 31, 2025 -- The U.S.

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Drugs.com

FEBRUARY 4, 2025

Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.Two. TUESDAY, Feb. 4, 2025 -- The U.S.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,

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Drugs.com

MARCH 19, 2024

DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.

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Drugs.com

DECEMBER 18, 2024

Food and Drug Administration (FDA) has issued its most serious warning -- a black-box warning -- for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but potentially severe liver. WEDNESDAY, Dec. 18, 2024 -- The U.S.

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DECEMBER 17, 2024

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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Drugs.com

MARCH 19, 2024

Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval.

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Chemical Biology and Drug Design

FEBRUARY 6, 2025

The study examines the frequency, distribution, prevalence, and diversity of oxygen atoms in a dataset of 2049 small molecules approved by the FDA and other agencies. This work presents a comprehensive analysis of oxygen atoms in approved drugs, aiming to streamline drug design and discovery efforts.

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FEBRUARY 19, 2025

Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S. leadership in medical devices are on the line.

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JULY 2, 2024

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

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MARCH 26, 2025

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

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JANUARY 8, 2025

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

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Drugs.com

MARCH 21, 2025

Food and Drug Administration has launched the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database to evaluate potential health risks of contaminants in foods.One of the FDA's roles is.

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