Pharmafile

APRIL 16, 2024

GSK has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The post GSK’s meningococcal vaccine candidate accepted for FDA review appeared first on Pharmafile.

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Vaccines FDA 64

Drug Topics

APRIL 17, 2024

Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.

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FDA 112

Drug Topics

APRIL 16, 2024

The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.

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Vaccines FDA 98

Pharmafile

MARCH 22, 2024

Idorsia has announced that the US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on prior treatments.

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FDA 105

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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FDA Insurance Labelling 120

pharmaphorum

APRIL 11, 2024

Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.

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FDA 119

OctariusRx

MARCH 25, 2024

Are FDA drug recalls important? If you’d like more details, or have a specific question about FDA drug recalls, reach out to us. The post Are FDA drug recalls important? Do you need to take them seriously? If so, what steps should you take to ensure your patients are safe and your facility is maintaining regulatory compliance?

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FDA 75

Fierce Pharma

APRIL 1, 2024

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

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FDA 109

pharmaphorum

APRIL 8, 2024

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

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FDA 110

STAT

FEBRUARY 20, 2024

Triple-check your data or we’ll reject your device, the FDA warned. The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance.

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FDA 141

pharmaphorum

APRIL 8, 2024

FDA approves AstraZeneca and Daiichi Sankyo’s Enhertu for all HER2-positive solid tumours, in a first for both the HER2 inhibitor and ADC category.

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FDA 111

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 92

Pharmacy Times

MARCH 8, 2024

The FDA is convening a committee to discuss phase 3 data after the planned action date, which delays drug availability to patients.

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FDA 149

The FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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FDA 139

pharmaphorum

APRIL 1, 2024

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

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FDA 111

Pharmafile

APRIL 5, 2024

UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Bimzelx (bimekizumab-bkzx), for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).

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FDA 64

Pharmafile

APRIL 15, 2024

Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CAN-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer. The post FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment appeared first on Pharmafile.

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FDA 59

pharmaphorum

MARCH 25, 2024

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

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FDA 111

Pharmafile

MARCH 4, 2024

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority review.

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Chemotherapy FDA 110

STAT

MARCH 28, 2024

WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?

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FDA Labelling 113

Pharmacy Times

MARCH 21, 2024

The FDA has only approved aprocitentan (Tryvio; Idorsia) in the 12.5 mg dosage as the effects were similar between the 25 mg and 12.5 mg dosages.

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Dosage FDA 138

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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Pharmaceutical Technology

APRIL 8, 2024

The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.

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FDA 105

Pharmafile

MARCH 15, 2024

The US Food and Drug Administration (FDA) has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), for use alongside diet and exercise.

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FDA 105

pharmaphorum

JANUARY 8, 2024

Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research told a packed house in San Francisco for JPM that FDA wants to support gene therapies in 2024.

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FDA 138

STAT

MARCH 26, 2024

By comparison, the FDA inspected 976 clinical study sites in 2017. And the FDA was unable to complete about 30% of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023.

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FDA Hospitals 108

pharmaphorum

MARCH 26, 2024

MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms

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FDA 111

Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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FDA 110

pharmaphorum

APRIL 3, 2024

Basilea Pharmaceutica gets US approval for its ceftobiprole antibiotic, around 15 years after the drug was first turned down by the FDA.

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FDA 104

Fierce Pharma

APRIL 4, 2024

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S.

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FDA 95

Fierce Pharma

MARCH 25, 2024

Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.<

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FDA 108

Fierce Pharma

APRIL 8, 2024

The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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FDA 108

pharmaphorum

MARCH 10, 2024

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.

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FDA 124

STAT

JANUARY 16, 2024

It’s the same potentially curative therapy cleared by the FDA in December to treat sickle cell disease. The expanded approval of the therapy, called Casgevy, was widely expected but came two months ahead of the FDA’s decision deadline, known as a PDUFA date.

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FDA 135

The Checkup by Singlecare

JANUARY 19, 2024

Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier?

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FDA Dosage Insurance 105

Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

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FDA 104