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

Drug Topics

FEBRUARY 21, 2025

Semaglutide has been in shortage since 2022 due to increased demand.

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FDA 190

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. FDA’s sampling and testing programme found 892 of 1,552 product samples (57.5

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FDA Labelling 105

Drug Topics

FEBRUARY 18, 2025

The FDA initially approved deucravacitinib (Sotyktu) in September 2022 to treat moderate-to-severe plaque psoriasis.

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FDA 190

pharmaphorum

MAY 18, 2022

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. — Bakul Patel (@_bakulpatel) May 16, 2022. The post Google gives ex-FDA digital health head Bakul Patel strategic role appeared first on. Bakul Patel.

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FDA 139

The Checkup by Singlecare

NOVEMBER 9, 2023

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

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Fierce Pharma

DECEMBER 29, 2022

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. Thu, 12/29/2022 - 14:42. aarmstrong.

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FDA 124

STAT

MARCH 26, 2024

In 2022, the health regulator inspected 537 hospitals and clinics that were conducting studies of medicines for which drug manufacturers were seeking approvals. By comparison, the FDA inspected 976 clinical study sites in 2017. Government Accountability Office.

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FDA Hospitals 131

STAT

JUNE 26, 2024

It’s the first step in carrying out a law that Congress passed in 2022, and it’s six months late. The guidance is long-awaited.

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FDA 126

STAT

DECEMBER 21, 2023

But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT. Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials.

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FDA 138

STAT

DECEMBER 14, 2023

Whichever the case, product recalls by the Food and Drug Administration and the Consumer Product Safety Commission (CPSC) more than doubled between 2018 and 2022, according to new research published on Wednesday by life sciences software company MasterControl. The higher volume of recalls can mostly be attributed to the FDA.

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FDA 115

STAT

JUNE 26, 2024

When Congress passed the Food and Drug Omnibus Reform Act (FDORA) in December 2022, it was hailed as a landmark step toward codifying diversity and inclusion in clinical trials. The FDA’s goal is to ensure that enrollment goals include clinically relevant study populations. But nearly half a year after a Dec.

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FDA 114

Fierce Pharma

DECEMBER 12, 2022

Mirati kicks off KRAS showdown with FDA approval for Krazati. Mon, 12/12/2022 - 18:14. Watch out, Amgen.

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FDA 116

Fierce Pharma

DECEMBER 15, 2023

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK.

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FDA 116

Fierce Healthcare

DECEMBER 9, 2022

FDA OKs bivalent COVID boosters for kids as young 6 months. Fri, 12/09/2022 - 07:49.

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FDA 113

Fierce Pharma

NOVEMBER 23, 2022

price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line. Wed, 11/23/2022 - 10:10. Sporting a $3.5M

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FDA 120

STAT

MAY 8, 2024

Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.

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FDA 140

STAT

JANUARY 19, 2024

Food and Drug Administration scolded Novartis for making false and misleading statements about a best-selling breast cancer treatment in a television ad in 2022. ” The FDA also objected to formatting. Continue to STAT+ to read the full story…

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FDA 132

Fierce Pharma

NOVEMBER 23, 2022

On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane. Wed, 11/23/2022 - 09:35.

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Vaccines FDA 112

STAT

DECEMBER 4, 2023

Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations. Specifically, there was a 79% drop in inspections of pharmaceutical manufacturing plants in foreign countries and a 35% decline in domestic facilities from 2019 to 2022.

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FDA 116

Pharmacy Times

MAY 16, 2023

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

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FDA 123

Fierce Pharma

DECEMBER 21, 2022

After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca. Wed, 12/21/2022 - 17:50.

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FDA 108

The Checkup by Singlecare

APRIL 15, 2025

Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. The FDA recently approved generic versions of two other GLP-1s , Victoza (liraglutide) and Byetta (exenatide). Is there a generic for Mounjaro?

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Compounding Dosage Compounding Pharmacies FDA 85

Fierce Pharma

DECEMBER 16, 2024

The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD). | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

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Labelling FDA 95

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. Clinical trials of the FDA approved Rykindo ®.

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FDA Labelling 122

The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response.

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FDA Immunization 110

PhRMA

MAY 8, 2023

Food and Drug Administration (FDA) issued a BPCA written request to the sponsor for studies in pediatric cGVHD patients. In  In August of 2022, the FDA approved the use of this medicine for the treatment of pediatric patients one year and older with cGVHD who have tried and failed on one previous medicine.

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FDA 261

STAT

OCTOBER 20, 2023

The update included 171 new products that use artificial intelligence and machine learning, including 155 authorized since August of 2022. The agency’s data indicate that, after a lull during the Covid-19 pandemic, the number of authorized devices in 2023 is expected to increase by more than 30% over the prior year.

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FDA Documentation 127

Pharmaceutical Technology

MARCH 25, 2024

The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.

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FDA 98

The Checkup by Singlecare

JANUARY 15, 2025

Food and Drug Administration (FDA), such as Rybelsus (oral semaglutide), Mounjaro (tirzepatide), Zepbound (tirzepatide), and Saxenda (liraglutide). While a regular pharmacy dispenses commercially manufactured FDA-approved medications, compounding pharmacies prepare customized medications tailored to individual patient needs, says Eric F.

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Compounding Compounding Pharmacies FDA Dosage 98

The FDA Law Blog

DECEMBER 22, 2022

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

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FDA Labelling 114

European Pharmaceutical Review

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche’s CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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FDA 105

Fierce Pharma

JULY 8, 2024

Since Roche gained approval for its eye disease medication Vabysmo in 2022, it has stormed a market dominated by Regeneron and Bayer’s Eylea. Since Roche gained approval for its eye disease medication Vabysmo in 2022, it has stormed a market dominated by Regeneron and Bayer’s Eylea.

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FDA 91

The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. This approval is noteworthy because in 2022 the FDA found nitrosamine impurities in certain samples of sitagliptin , raising concerns about potential shortages of these two drugs.

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FDA Dosage 98

Fierce Pharma

AUGUST 2, 2023

FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022. Intas Pharmaceuticals’ new warning letter from the U.S.

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FDA 90

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology.

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FDA 98

Pharmacy Times

DECEMBER 11, 2023

Seven new agents have received FDA approval since October 2022.

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FDA 122