Drug Topics

DECEMBER 4, 2023

An evaluative study on an open resource Instagram page that provides information on new medications to pharmacists was recently presented at the American Society of Health-System Pharmacists 2023 Midyear Clinical Meeting and Exhibition.

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FDA 530

Drug Topics

NOVEMBER 8, 2023

The drug, Zepbound, will be available in the United States by the end of 2023.

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FDA 504

Drug Topics

MARCH 29, 2023

Naloxone hydrochloride nasal spray (Narcan) 4 mg is expected to be available over the counter in late summer 2023.

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FDA 460

STAT

APRIL 4, 2025

The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes. The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines.

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Drug Topics

MARCH 14, 2023

The product, called Lenire, uses bimodal stimulation and will be available in April 2023

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FDA 469

Drug Topics

JANUARY 20, 2023

The PDUFA date has been set for May 22, 2023.

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FDA 468

Drug Topics

FEBRUARY 21, 2024

The novel drug elranatamab-bcmm (Elrexfio) received accelerated FDA approval on August 14, 2023, for treating adults with relapsed or refractory multiple myeloma.

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FDA 468

Drug Topics

FEBRUARY 22, 2024

On January 6, 2023, the FDA granted lecanemab-irmb (Leqembi) accelerated approval for treating mild cognitive impairment and mild dementia in patients with Alzheimer disease.

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FDA 464

Drug Topics

FEBRUARY 15, 2024

In 2023, the FDA approved six vaccines, including several important firsts. Innovation in the vaccine area continues. But they face a difficult landscape where federal policies dictate coverage.

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Vaccines Insurance FDA 461

Drug Topics

DECEMBER 1, 2022

It is currently under review by the FDA and a decision is expected by January 6, 2023. Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease.

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FDA 469

Drug Topics

MARCH 9, 2023

21, 2023, and will potentially expand the drug to children 5 and under. Voxzogo is already available for patients over 5 years with a genetic cause of dwarfism. The PDUFA date is set for Oct.

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FDA 448

STAT

APRIL 4, 2025

As a longtime dog owner, I assumed that each bag of my dogs’ commercial pet food was closely monitored by the federal Food and Drug Administration (FDA). The resulting pet food industry is massive — Americans spent $65 billion on pet food and treats in 2023 alone. It turns out I was wrong. More than 102 million U.S.

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FDA 107

Drug Topics

AUGUST 18, 2023

NIH establishes research centers for maternal health, FDA grants priority review for IgA nephropathy treatment, and the CDC begins tracking a new COVID-19 variant.

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FDA 247

Drug Topics

AUGUST 25, 2023

HHS awards money for mental health awareness training, UnitedHealthcare pays $80,000 over potential HIPPA violation, and the FDA issues a recall for sub-acute care ventilators.

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FDA 247

Drug Topics

AUGUST 24, 2023

CVS Health joins the biosimilar market, the FDA issues warning about contaminated eye drops, and the CDC says not to kiss your pet turtle because of salmonella.

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FDA 247

Drug Topics

SEPTEMBER 1, 2023

The FDA plans to finalize its ban on menthol tobacco products in the coming months, and the Department of Health and Human Services proposes comprehensive staffing requirements for nursing homes.

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Nursing Homes FDA 247

Drug Topics

AUGUST 31, 2023

The FDA issues warning letters to 3 infant formula manufacturers for violations, and officials with the Department of Health and Human Services recommend reclassifying marijuana as a schedule III drug.

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FDA 247

Drug Topics

AUGUST 15, 2023

Philips recall declared class I by the FDA, HHS launches civil rights investigation into Tennessee medical center, and experts warn about chemicals released into air and water during Maui wildfires.

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FDA 247

Drug Topics

MARCH 21, 2023

Here’s a look back at the cancer drugs that gained FDA approval in the winter of 2023.

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FDA 247

Drug Topics

SEPTEMBER 14, 2023

FDA sends warning letters to 8 companies over unapproved eye drops, healthcare visits delivered by nurse practitioners and physician assistants continue to increase, and WHO agrees on the first-ever patient safety rights charter.

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FDA 247

Drug Topics

JUNE 6, 2023

Merck sues the federal government, the FDA will allow cancer drug imports from China, and a drug from GSK shows promise for endometrial cancer treatment.

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FDA 247

Drug Topics

JUNE 9, 2023

Advisers with the FDA endorse a monoclonal antibody treatment for RSV in children, AstraZeneca and Quell sign a $2 billion agreement, and HSS hopes to strengthen the pediatric workforce.

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FDA 247

Drug Topics

MARCH 23, 2024

The first nonprescription, OTC naloxone nasal spray (Narcan) was approved by the FDA in March 2023.

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FDA 309

Drug Topics

JULY 18, 2024

The drug was FDA approved as antihemophilic factor (recombinant), Fc-VWF-XTEN Fusion Protein-ehtl (Altuviiio) in February 2023.

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FDA 282

Drug Topics

FEBRUARY 7, 2023

5, 2023 by the FDA. Zuranolone, a fast-acting neuroactive steroid that can take effect in 14 days, has been assigned a PDUFA action date of Aug. It can be used to treat patients with major depressive disorder and postpartum depression.

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FDA 190

Drug Topics

APRIL 19, 2023

The expected PDUFA date is December 16, 2023.

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FDA 247

Drug Topics

FEBRUARY 28, 2023

The PDFUA date for the drug is October 13, 2023.

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FDA 247

Drug Topics

NOVEMBER 3, 2023

Attendees at an AMCP Nexus session received an overview of FDA approvals granted in 2023 as well as a preview of nononcology drugs to be released over the next 5 years.

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FDA 282

Pharmacy Times

OCTOBER 3, 2023

NVX-CoV2601 vaccine adjuvanted 2023-2024 formula granted EUA for the prevention of COVID-19 in those 12 years of age and older.

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Vaccines FDA 145

Pharmacy Times

JULY 7, 2022

The FDA approved a licensure request for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent for use in the upcoming 2022-2023 flu season, providing influenza vaccination for adults 65 years of age and older.

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Vaccines FDA 123

pharmaphorum

JANUARY 9, 2023

Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. The post JP Morgan 2023 – Day 1 appeared first on. Check below for updates throughout the day.

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The FDA Law Blog

APRIL 21, 2025

Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. Thats all bad news if your timeline depends on FDA sticking to theirs. By John W.M. Claud & Michelle L.

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Documentation FDA 64

Fierce Pharma

APRIL 19, 2023

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

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Vaccines FDA 145

PharmaVoice

FEBRUARY 6, 2023

From Roche’s new pharma chief to the departure of the FDA’s gene therapy head, these moves are bound to shake up the industry.

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FDA 130

Fierce Pharma

MAY 19, 2023

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

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FDA 143

STAT

JUNE 13, 2024

The day an FDA advisory committee met to weigh the merits of an experimental treatment for amyotrophic lateral sclerosis was one of the worst of Mitze Klingenberg’s life.    Her son Matt had benefited, she said, from an ALS treatment under review for approval by the Food and Drug Administration.

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STAT

JANUARY 4, 2023

Continuing economic uncertainty and the threat of a recession are casting a pall over health tech in 2023 — a dramatic shift for an industry that enjoyed abundant funding in the pandemic’s early stages.   Continue to STAT+ to read the full story…

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FDA 145