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

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

PharmaVoice

DECEMBER 6, 2023

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

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FDA Vaccines 264

Drug Topics

SEPTEMBER 13, 2023

The CDC weighs in on updated COVID-19 vaccines, the FDA says phenylephrine is ineffective, and heath care workers in California get a pay raise.

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Vaccines FDA 247

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

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 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.

FDA 247

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.

FDA 247

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.

FDA 247

FDA 247

Drug Topics

SEPTEMBER 12, 2023

CDC to weigh who should get updated COVID-19 vaccines after FDA approval, Novavax says its updated COVID-19 vaccine is ready for distribution, and Walgreens partners with Pearl Health to expand primary care services.

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Vaccines 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.

FDA 247

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 307

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 281

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

MARCH 1, 2024

Pfizer's RSV vaccine received FDA approval on May 31, 2023.

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Vaccines FDA 281

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 281

Drug Topics

NOVEMBER 23, 2023

The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.

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Vaccines FDA 247

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

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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FDA 119

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

IDStewardship

APRIL 14, 2024

These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. 2023 Nagarakanti S, Orenstein R. Gut Microbes.

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FDA Hospitals Communication 331

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

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 144

Fierce Healthcare

JANUARY 27, 2023

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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Vaccines FDA 128