Drug Topics

SEPTEMBER 11, 2023

Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.

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Vaccines FDA 209

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Labelling FDA 52

Pharmacy Times

APRIL 12, 2024

In addition to oral administration, patients with partial-onset seizures can now take the antiseizure medication via a nasogastric tube if the tablet is crushed and mixed with water.

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FDA 156

Pharmacy Times

DECEMBER 14, 2023

The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.

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Labelling FDA 139

The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

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FDA Documentation 59

Pharmafile

MARCH 7, 2023

Global biotechnology company BioMarin Pharmaceutical has announced that it’s received an update from the FDA, detailing the extension of their review of the company’s Biologics License Application (BLA) for Roctavian™. read more

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FDA Communication 59

The FDA Law Blog

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). It authorized FDA oversight over mammography facilities.

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FDA 59

Pharmacy Times

APRIL 26, 2024

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

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Labelling FDA 65

Drug Topics

DECEMBER 18, 2023

The federal agency also removed the maximally tolerated qualifier for statin use and the prior cardiovascular morbidity and mortality limitation of use statement.

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FDA 123

pharmaphorum

FEBRUARY 24, 2021

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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Vaccines FDA Immunization 59

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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FDA Documentation Communication 45

Drug Topics

APRIL 26, 2024

Check out important updates from the FDA for the week of April 22.

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FDA 98

PharmExec

APRIL 26, 2024

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

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Labelling FDA 52

Drug Topics

APRIL 19, 2024

Check out important updates from the FDA for the week of April 15.

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FDA 112

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. The post Update: FDA clears first generic of AZ’s blockbuster Symbicort appeared first on.

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FDA 59

Drug Topics

JUNE 23, 2023

Pending authorization of the XBB.1.5 vaccine, the company said that doses would be available in time for fall vaccination.

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Vaccines FDA 98

Fierce Pharma

SEPTEMBER 28, 2023

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

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Labelling FDA 115

STAT

JUNE 15, 2023

The Covid-19 vaccines are on track for a big recipe change this fall. Today’s vaccines still contain the original coronavirus strain, the one that started the pandemic — even though that was long ago supplanted by mutated versions as the virus rapidly evolves. Read the rest…

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Vaccines FDA 108

Fierce Pharma

MARCH 18, 2024

After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens in hopes of reaching a broader patient population. And AstraZeneca, utilizing a similar immunotherapy strategy, has also come up with a rivaling update as it awaits an FDA decision.

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FDA 115

Pharmacy Times

AUGUST 31, 2022

With these bivalent vaccine authorizations, the monovalent mRNA COVID-19 vaccines are still not authorized as booster doses for individuals 12 years of age and older.

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Vaccines FDA 123

STAT

DECEMBER 8, 2022

The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.

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FDA Vaccines 98

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 98

Outsourcing Pharma

AUGUST 19, 2021

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.

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FDA 98

Pharmaceutical Technology

OCTOBER 4, 2023

The US FDA has amended the EUA of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023-2024 formula.

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Vaccines FDA 69

The FDA Law Blog

OCTOBER 12, 2023

Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition.

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FDA Dosage 59

BioPharm

APRIL 17, 2024

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

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FDA 52

Drug Topics

OCTOBER 27, 2023

The third part of the series features HCP education on key updates in the management of COVID-19. A simulated pharmacist/patient encounter is also included which highlights best practices for incorporating FDA and CDC recommendations for patients with COVID-19.

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FDA 98

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 98

Outsourcing Pharma

SEPTEMBER 10, 2021

The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.

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FDA Vaccines 85

Outsourcing Pharma

FEBRUARY 9, 2021

The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.

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FDA 96

STAT

OCTOBER 12, 2022

The Food and Drug Administration on Wednesday authorized updated Covid-19 boosters for kids as young as 5.     Previously, the newer versions of the shots — which target both the original strain of the coronavirus as well as the dominant BA.5 Read the rest…

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FDA Vaccines 98

BioPharm

SEPTEMBER 8, 2023

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

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Documentation FDA 52

Outsourcing Pharma

DECEMBER 14, 2021

The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.

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Vaccines FDA 97

STAT

MARCH 30, 2023

The Food and Drug Administration on Thursday released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update products already being used in the clinic.

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Documentation FDA 104

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

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FDA Documentation Vaccines 133

Pharmaceutical Commerce

JANUARY 16, 2024

Trial shows 52% of patients with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement administered Dupixent experienced a clinically meaningful reduction in itch on hands and feet vs. 14% with placebo.

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Labelling FDA 52

Pharmacy Times

SEPTEMBER 12, 2022

Modification is based on phase 3 FIGARO-DKD clinical trial investigating CV and kidney outcomes in more than 13,000 patients with CKD associated with type 2 diabetes.

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Labelling FDA 73