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Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use

Fierce Pharma

The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations. Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer.

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Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data

Fierce Pharma

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 approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

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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Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fierce Pharma

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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer

Fierce Pharma

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

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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