Pharmafile

JULY 25, 2024

BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, a conditionally and reversibly active ROR2 antibody drug conjugate (ADC). The post BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin appeared first on Pharmafile.

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FDA 69

STAT

JULY 19, 2024

Yet more than a month later, ICER chief medical officer David Rind — along with others who’ve raised concerns about Lykos’ management of the trials — told STAT they’ve yet to hear from the FDA, which is set to decide by Aug. 11 whether MDMA can be used to treat post-traumatic stress disorder.

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FDA 137

Drug Topics

JULY 22, 2024

Check out important updates from the FDA from over the past week.

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FDA 112

Drug Topics

JULY 2, 2024

Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.

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FDA 123

pharmaphorum

JULY 22, 2024

The recent action by the FDA mandates that trial sponsors must consider diversity in clinical trials. Learn more about the importance of diversity and inclusion in medical research.

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FDA 97

Drug Topics

JUNE 18, 2024

The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

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Vaccines FDA 200

pharmaphorum

JULY 19, 2024

FDA will create a rare disease hub to speed the development of new treatments and build connections between developers and the rare disease community

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FDA 116

Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Vaccines FDA 145

The FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Communication Documentation 111

pharmaphorum

JULY 11, 2024

FDA rejects Novo Nordisk’s once-weekly basal insulin for people with diabetes, which would reduce the number of injections needed

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FDA 111

Pharmacy Times

FEBRUARY 12, 2024

The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.

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FDA 145

STAT

JUNE 17, 2024

Today, we talk about the uptick in physicians using ctDNA to determine if resected cancers are truly gone, we see the FDA offering new guidelines for Covid-19 vaccines, and more.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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Vaccines FDA 113

Pharmacy Times

JUNE 17, 2024

The FDA approved blinatumomab for treatment of patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

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FDA 139

Fierce Pharma

JUNE 26, 2024

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered partnered antibody drug conjugate (ADC) patritumab deruxtecan. |

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FDA 137

Pharmafile

MAY 15, 2024

Roche has announced that the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-collection solution. The post FDA approves Roche’s HPV self-collection screening option appeared first on Pharmafile.

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FDA 105

STAT

JUNE 13, 2024

The day an FDA advisory committee met to weigh the merits of an experimental treatment for amyotrophic lateral sclerosis was one of the worst of Mitze Klingenberg’s life.    Her son Matt had benefited, she said, from an ALS treatment under review for approval by the Food and Drug Administration.

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FDA 124

STAT

JULY 2, 2024

The drug was originally expected to be approved earlier this year, but the FDA convened a panel of advisers to weigh the risks and benefits of the treatment. Both therapies are monoclonal antibodies designed to clear amyloid in the brain. The clearance of Kisunla comes after several regulatory hurdles.

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FDA 142

Fierce Pharma

JULY 19, 2024

A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind a recent FDA rejection. A 10-observation Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind its recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. |

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FDA 95

Drug Topics

MAY 6, 2024

Mycophenolate mofetil oral suspension is the only FDA-approved ready-to-use liquid formulation.

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FDA 199

Pharmacy Times

JUNE 25, 2024

The supplemental new drug application (sNDA) for brexpiprazole is accepted by the FDA for treatment of patients with post-traumatic stress disorder (PTSD).

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FDA 123

pharmaphorum

JUNE 11, 2024

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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FDA 114

pharmaphorum

JULY 10, 2024

After short but worrying delay, Arcutis gets FDA approval for flagship drug Zoryve in atopic dermatitis, which could further unlock sales growth

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FDA 116

STAT

MAY 29, 2024

The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. When the FDA finalized its test regulation plan last month, several experts said it was only a matter of time until someone in the lab industry sued.

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FDA 129

STAT

JULY 16, 2024

CHICAGO – The FDA’s top food regulator contended Tuesday that the agency could not have done much more to prevent the recent contamination of children’s applesauce with lead.

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FDA 129

Pharmafile

MARCH 25, 2024

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).

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FDA 111

STAT

JUNE 21, 2024

ORLANDO — The United States is at a critical juncture in its efforts to treat chronic diseases, particularly type 2 diabetes, and now has a chance to change the dangerous trajectory it’s currently following, FDA Commissioner Robert Califf said Friday. “The U.S.

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FDA 129

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

Pharmafile

APRIL 29, 2024

Pfizer has announced that the US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe haemophilia B. The post Pfizer’s Beqvez approved by FDA for haemophilia B treatment appeared first on Pharmafile.

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FDA 105

Pharmafile

MAY 17, 2024

Amgen has announced that the US Food and Drug Administration (FDA) has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have had disease progression on or after platinum-based chemotherapy.

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FDA Chemotherapy 111

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 133

pharmaphorum

MAY 21, 2024

FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.

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FDA 119

pharmaphorum

JULY 3, 2024

Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.

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FDA 113

STAT

JUNE 7, 2024

Prior to this FDA decision, Arexvy was licensed for use in people 60 and older. The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50. Read the rest…

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Vaccines FDA 141

pharmaphorum

JUNE 23, 2024

Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug that it hopes could find a use in more than a dozen diseases.

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FDA 115

STAT

APRIL 29, 2024

The tests have not faced FDA scrutiny historically, as the agency considered them low-risk. But the tests have grown in power and complexity since the FDA first started regulating medical devices in 1976. The infamous faulty blood tests from Theranos fall into this category, as well as misleading prenatal genetic tests.

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FDA 111

Pharmafile

JULY 26, 2024

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation. ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau).

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FDA Immunization 64

STAT

JULY 10, 2024

This comes after the FDA in May convened a group of advisers to discuss the drug, called icodec. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.

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FDA 117