Fierce Pharma

MARCH 27, 2024

Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.

FDA Approval 111

FDA Approval Marketing Drugs 111

pharmaphorum

MARCH 26, 2024

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier application was turned down with a request for changes to the risk evaluation and mitigation strategy (REMS) for the drug.

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XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older.

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FDA Approval Genetics Gene Therapy Gene 105

FDA Law Blog

MARCH 29, 2024

Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. The vast majority are for drugs.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

Drug Discovery World

MARCH 29, 2024

FDA approves Covid-19 mAb for emergency use The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis of Covid-19.

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Drugs FDA Approval Antibody Trials 52

FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form. Teva’s patents do not meet that criterion.

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Production Drugs Containment Generic Drugs 59

Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

Roots Analysis

MARCH 26, 2024

In fact, the initial stage of lockdown featured the fragile nature of pharmaceutical supply chain as a result of plant shutdowns and subsequent drug shortages. In fact, drug manufacturers are moving faster than ever to cope up with the drug shortages. Specifically, in the pharmaceutical industry, the standstill days are over.

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Manufacturing Production Marketing Drugs 52

XTalks

MARCH 26, 2024

Does CNS Drug Development Need to Evolve to Include Objective, Longitudinal and Broad-Spectrum Data? The approved therapies for bipolar disorder span many categories, including medications, psychotherapeutic approaches and adjunct or alternative treatments in some instances.

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XTalks

MARCH 28, 2024

Keytruda (pembrolizumab): This is an immunotherapy drug for patients suffering from metastatic CRC having MSI-H or dMMR. Tukysa (tucatinib) plus Herceptin (trastuzumab): The FDA has approved this treatment for certain individuals with CRC characterized by overexpression of HER2 proteins in their tumors.

Gene Editing 59

Gene Editing Life Science Clinical Trials Clinical Trials 59

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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FDA Approval Clinical Trials Clinical Trials Trials 81

FDA Law Blog

MARCH 26, 2024

Sasinowski — On March 21st, FDA announced the approval of the first nonsteroidal therapy for the treatment of Duchenne Muscular Dystrophy (DMD) (FDA press release available here ). Beyond the unmet medical needs that Duvyzat helps to address, we see this approval to be notable from a drug development and regulatory perspective.

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FDA Approval Trials Genetics Drugs 59