Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

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Food and Drug Administration FDA Medical science Food 98

Clarivate

MARCH 8, 2023

In recent years, there has been an increased focus on real world evidence to advance medical science and improve patient quality of life. The suitability of RWD, the FDA said in a 2017 guidance report , depends on its relevance (whether data directly addresses intended use) and reliability (completeness, accuracy and timeliness) [2].

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Patients Biopharma Medical science Electronics 59

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. Can you share some highlights from the data presented at ASH 2023? The IND for the combination was cleared in May 2023 and we have now treated patients in the first two cohorts.

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Food and Drug Administration Patients Safety Medical science 84

Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, the drug's closest TIL competitor, Iovance Biotherapeutics’ lifileucel, has begun a rolling BLA for advanced melanoma patients and could reach the market as early as Q3 2023. In April this year, the FDA provided new feedback on the potency assays, which Iovance indicated will be addressed in the latest BLA.

Manufacturing 59

Manufacturing Food and Drug Administration Medical science Patients 59

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. This trial is anticipated to begin in the second half of 2023. Biologics Global Market Report 2023. 2023 [cited 2023Feb]. References Urquhart L. Top companies and drugs by sales in 2021. 2022;21(4):251–.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 92

Medgadget

FEBRUARY 17, 2023

Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. Here’s an excellent video of the HandX used in clinical practice: Product page: Human Xtensions HandX… Biomed Israel , is the leading international Life Science and HealthTech conference in Israel.

Physicians 80

Physicians Engineering Side effects Leads 80

Medgadget

MARCH 2, 2023

The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. This will hopefully lead to an FDA approval for its first indication, after which Alpha TAU plans on expanding to other types of cancer and geographic regions such as Europe and Japan. The rest of the patients had partial responses.

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