Drug Topics

JULY 6, 2023

The Humira biosimilar is a tumor necrosis factor (TNF) blocker and was approved by the FDA in 2021.

FDA 247

FDA 247

pharmaphorum

JANUARY 28, 2021

It’s important that the biosimilar market continue to build on the success established last year in 2021. Based on this momentum, we’re making three predictions for 2021: we will see increased competition within individual markets pay off, expansion in the biosimilar channel to include new therapeutic categories, and more regulatory support.

Insurance Coverage 119

Insurance Coverage FDA Insurance 119

Pharmacy Times

OCTOBER 13, 2022

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

FDA 154

FDA 154

pharmaphorum

JANUARY 25, 2021

Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. I believe 2021 promises to be a year of industry-wide introspection, assessment and analysis. Sponsors will want to capitalise on the heightened public interest during 2021 and beyond by building trust.

Communication 124

Communication Patient Care FDA 124

Pharmacy Times

MAY 22, 2023

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

FDA 129

FDA 129

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.

FDA 128

FDA 128

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.

FDA 120

FDA Labelling Insurance 120

Pharmaceutical Technology

JANUARY 24, 2025

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

FDA 102

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.

FDA 98

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.

FDA 112

FDA 112

pharmaphorum

SEPTEMBER 24, 2020

An artificial intelligence-powered diagnostic for autism spectrum disorder (ASD), developed by Cognoa, has met all its objectives in a pivotal trial and will be filed for approval with the FDA. That would cut the review time down to six months, making a 2021 approval very possible. Photo by natsuki on Unsplash.

FDA 134

FDA 134

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.

FDA 119

FDA 119

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.

FDA 102

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.

FDA 128

FDA Adverse Reactions 128

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…

FDA 110

FDA 110

pharmaphorum

JANUARY 5, 2021

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. — Sandip Patel MD (@PatelOncology) January 2, 2021.

Vaccines 126

Vaccines FDA 126

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.

FDA 122

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.

FDA 124

FDA Chemotherapy Labelling Immunization 124

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. billion in the first nine months of 2021, helped by additional approvals in severe asthma and chronic rhinosinusitis with nasal polyposis.

FDA 111

FDA Labelling 111

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.

FDA 105

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?

FDA 105

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.

FDA 97

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.

FDA 111

FDA Immunization 111

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.

FDA 120

FDA 120

The FDA Law Blog

AUGUST 16, 2022

Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B. Mr. Cruse pledged that the frequency of these inspections would increase.

FDA 98

FDA 98

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.

FDA 98

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,

FDA 90

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.

FDA 98

FDA Packaging Insurance 98

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.

FDA 93

FDA 93

pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). The post FDA turns down Amryt’s epidermolysis bullosa drug appeared first on.

FDA 98

FDA 98

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

Dosage 115

Dosage FDA Pharmaceutical Companies Pharmaceutical Companies 115

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.

FDA 98

FDA 98

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.

FDA 93

FDA 93

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.

FDA 98

FDA Dosage Insurance 98

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.

FDA 98

FDA Dosage 98

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.

Vaccines 105

Vaccines FDA 105

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

FDA 98

FDA Labelling 98