Pharmacy Times

OCTOBER 13, 2022

Keynote speaker at the AMCP Nexus conference discusses recent FDA approvals and those scheduled over the next year.

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FDA 154

STAT

MAY 23, 2024

The expert panel spent hours listening to presentations from Guardant, the FDA, and members of the public before voting on the screening test, called Shield. In 2021, CMS denied coverage for Epi proColon, a different blood-based colon cancer test approved by the FDA.

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FDA 139

Pharmacy Times

MAY 22, 2023

Avapritinib has been FDA approved for the treatment of advanced systemic mastocytosis since June 2021.

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FDA 129

The Checkup by Singlecare

JANUARY 31, 2025

Food and Drug Administration (FDA) expanded Ozempics indication to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). Other approved uses of semaglutide This is not the first time that the FDA has expanded the use of semaglutide.

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FDA 66

STAT

OCTOBER 9, 2024

  Those applications and more appeared in a recent analysis of AI in FDA drug and biologic submissions through 2021. The report was co-authored by Tala Fakhouri, who now co-leads an AI Council that FDA’s Center for Drug Evaluation and Research established in late August.

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FDA 133

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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Pharmaceutical Technology

JANUARY 24, 2025

The FDA rejected the companys initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

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FDA 102

Pharmaceutical Technology

APRIL 30, 2024

The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.

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FDA 98

Fierce Pharma

DECEMBER 15, 2023

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.

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FDA 112

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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STAT

NOVEMBER 13, 2024

Between November 2021 and this past June, the vacancy rate among investigators increased to 16% from 9%. Meanwhile, the FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, down 36% from fiscal year 2019. government watchdog found. Continue to STAT+ to read the full story…

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FDA 121

pharmaphorum

JUNE 10, 2024

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

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FDA 102

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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 111

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. Clinical trials of the FDA approved Rykindo ®. The company stated development of Rykindo ® in Europe is progressing.

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FDA Labelling 122

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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FDA Chemotherapy Labelling Immunization 124

The FDA Law Blog

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different.

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FDA Documentation Medical Records 105

The Checkup by Singlecare

AUGUST 12, 2024

Food and Drug Administration (FDA) approved neffy, a nasal spray for the emergency treatment of anaphylaxis. The approval comes more than three decades after epinephrine was first approved by the FDA for the treatment of anaphylaxis in 1987. On August 9, the U.S. No serious adverse effects were reported. When will neffy be available?

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FDA Insurance 105

Fierce Pharma

OCTOBER 17, 2023

After the FDA requested more data in 2021, Ardelyx instead defended its drug's profile through two appeals and an advisory committee meeting. The third time’s the charm for Ardelyx and its chronic kidney disease med Xphozah (tenapanor). Now, the company can celebrate a long-awaited win.

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FDA 97

pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The FDA said it should have been advised of the proposed changes before Ampio unblinded and analysed the data from the AP-013 study.

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Pharmacy Times

DECEMBER 12, 2024

This update follows May 2021 guidelines which recommended patients with primary biliary cholangitis (PBC) with advanced cirrhosis discontinue obeticholic acid.

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FDA 120

STAT

JANUARY 10, 2023

As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a review of FDA data on clinical holds. The agency halted clinical trials for experimental drugs an average of 664 times each year from 2017 to 2021, up from 557 each of the previous five years.

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FDA 97

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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FDA Documentation 98

Fierce Pharma

MARCH 13, 2024

FDA has OKed Mirum’s Livmarli to treat the rare liver disease PFIC. The nod comes on top of another for Livmarli to treat Alagille syndrome in 2021,

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FDA 90

The Checkup by Singlecare

MARCH 31, 2023

Food and Drug Administration (FDA) approved a non-prescription version of Narcan (naloxone), a nasal spray used to rapidly reverse the effects of an opioid overdose. According to the FDA, drug overdose is a persistent public health problem in the United States. This week the U.S. chief medical officer of Toolbox Genomics.

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STAT

MAY 20, 2024

It was late 2021, and Campbell was nearing the end of a clinical trial testing out a device to help paralyzed patients regain movement. One of them, jarringly, was his body’s inability to sweat. So when Campbell started sweating on his stationary bike for the first time in seven years, it felt surreal.

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FDA 134

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

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FDA 98

STAT

SEPTEMBER 19, 2023

This population represents less than 2% of all premature babies, but the problem is growing; the Centers for Disease Control and Prevention reported that the preterm birth rate rose by 4% between 2020 and 2021. Continue to STAT+ to read the full story…

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FDA 129

The Checkup by Singlecare

MARCH 13, 2024

Food & Drug Administration (FDA) approved Jubbonti and Wyost, the first interchangeable biosimilars to the injectable medications Prolia and Xgeva , respectively. For traditional medications, the FDA can approve generic medications. In other words, biosimilars go through the same FDA approval process as all other medications.

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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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European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. percent of whooping cough cases in 2021 were those six months or younger.

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Vaccines FDA 105

Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. The regulator had previously granted breakthrough therapy and orphan drug designations to Vowst.

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FDA 98

STAT

NOVEMBER 15, 2023

Between 2004 and 2021, a U.S. Of those 36 cases, two-thirds involved 34 patents that covered medical products regulated by the FDA. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis.

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FDA 128

European Pharmaceutical Review

NOVEMBER 22, 2022

The US Food and Drug Administration ( FDA ) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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FDA Labelling 98

STAT

OCTOBER 4, 2023

At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. Some Wall Street analysts are now betting the FDA will ask Amgen to run yet another trial or maybe withdraw the drug altogether. Continue to STAT+ to read the full story…

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Documentation FDA 134

STAT

DECEMBER 18, 2023

and Europe in August 2021 , STAT writes. The September 2021 inspection took place at Moderna’s facility in Norwood, Mass., The decision followed a ruling of the U.S. Fifth Circuit Court of Appeals, which held that the merger was anti-competitive.

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FDA Vaccines 103

Fierce Pharma

SEPTEMBER 14, 2024

In 2021, the FDA blasted Merck for using a premature endpoint to pursue a Keytruda approval in early-stage triple-negative breast cancer (TNBC). | In 2021, the FDA blasted Merck for using premature data to pursue a Keytruda approval in early-stage triple-negative breast cancer.

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FDA 86