Fierce Pharma

JANUARY 18, 2024

AstraZeneca charts new course for Imfinzi in liver cancer, but FDA path remains uncertain aliu Thu, 01/18/2024 - 14:27

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FDA 146

PharmaVoice

JANUARY 12, 2024

Following a year where the FDA approved 55 new drugs, the 2024 PDUFA calendar is set with a number of potentially buzzy approvals.

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FDA 52

Fierce Pharma

FEBRUARY 28, 2024

After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. The company is eying four new indications and potential peak sales of 4 billion euros.

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FDA Sales 226

MedCity News

DECEMBER 11, 2023

Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations.

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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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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Manufacturing FDA Safety Pharma 59

MedCity News

OCTOBER 9, 2023

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.

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Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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FDA 111

MedCity News

OCTOBER 2, 2023

Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.

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Pharmaceutical Technology

MARCH 11, 2024

The FDA is still likely to approve donanemab, however, the delay will benefit Eisai and Biogen in allowing Leqembi to gain greater traction in the Alzheimer's market.

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FDA Marketing 52

Pharmaceutical Commerce

AUGUST 30, 2023

Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.

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FDA 105

Pharmaceutical Technology

DECEMBER 20, 2023

The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024

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Food FDA 97

Fierce Pharma

FEBRUARY 7, 2024

were receiving the amyloid-busting antibody as of Jan. 26, Eisai explained in a third-quarter earnings presentation.

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FDA Patients 219

MedCity News

MAY 3, 2023

FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.

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FDA Biopharma Pharma 100

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). However, he did note that Stelara does have a composition of matter patent expiry in mid-2024 in Europe. US sales of Stelara totalled $6.4

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Food and Drug Administration FDA Side effects Safety 92

Fierce Pharma

JUNE 15, 2023

An approval now looks within reach for 2024. An approval now looks within reach for 2024. After acing a study for the induction treatment of ulcerative colitis, AbbVie’s Skyrizi has snatched another win in a maintenance trial.

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FDA 165

Pharmaceutical Technology

MARCH 8, 2024

While Lilly’s Alzheimer’s drug was previously expected in Q1 2024, an FDA-mandated review at an unknown date means a decision may be delayed.

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FDA 52

PharmExec

FEBRUARY 21, 2024

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

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Pharmatutor

JANUARY 12, 2024

Overview of FDA Drug approvals in 2023 - Total Guide admin Sat, 01/13/2024 - 11:38 In 2023, FDA approved 55 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as expanding the use or patient population of previously approved drugs.

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Pharmaceutical Commerce

FEBRUARY 20, 2024

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

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FDA Prescription 52

Pharmaceutical Commerce

FEBRUARY 20, 2024

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

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FDA 101

Pharmaceutical Technology

FEBRUARY 21, 2024

A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.

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FDA 52

Pharmaceutical Technology

FEBRUARY 13, 2024

Two FDA representatives FDA spoke at the ongoing 2024 SCOPE Summit about how the agency is focusing on AI.

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FDA 52

PharmaTech

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 64

Pharmaceutical Technology

FEBRUARY 19, 2024

An FDA approval in late 2024 would make it the first TROP2-directed therapy for NSCLC antibody drug conjugate patients.

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FDA Patients 52

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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FDA 69

Pharmacy Times

AUGUST 28, 2023

The start date of the package-level electronic tracking system will shift from November 27, 2023 to November 27, 2024.

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Electronics FDA 48

Pharmaceutical Commerce

JANUARY 24, 2024

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

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FDA Prescription 52

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

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Sales FDA 247

PharmExec

FEBRUARY 20, 2024

The FDA assigned the supplemental new drug application for Krazati (adagrasib) plus cetuximab in patients with locally advanced or metastatic colorectal cancer with a Prescription Drug User Fee Act goal date of June 21, 2024.

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FDA Prescription Patients 52

Clarivate

JANUARY 8, 2024

The annual Clarivate Drugs to Watch report for 2024 features 13 new therapeutics with standout commercial and/or clinical potential. FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. The post What sets the Drugs to Watch in 2024 apart appeared first on Clarivate.

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Marketing Patients Healthcare Healthcare 59

MedCity News

MARCH 21, 2023

Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.

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FDA Biopharma Pharma 90

European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The FDA is expected to decide on approval of Xolair for patients with food allergies in the first quarter of 2024.

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Food Food and Drug Administration FDA Patients 97

Pharmaceutical Technology

NOVEMBER 28, 2023

Aldeyra has submitted new trial plans to the US FDA, and anticipates NDA resubmission for reproxalap in H1 2024.

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FDA 59

MedCity News

DECEMBER 5, 2023

Replimune’s lead therapeutic candidate did not meet the two main goals of a study intended to support an FDA submission in cutaneous squamous cell carcinoma. But Replimune’s therapy, an oncolytic virus, has better data in melanoma, and the company plans a 2024 FDA submission in this skin cancer.

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PharmExec

DECEMBER 5, 2023

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

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FDA 52

Pharmacy Times

OCTOBER 17, 2023

The committee will help the FDA address issues related to digital health technologies, including artificial intelligence, virtual reality, cyber security, and patient-generated health data.

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