FDA - International Biopharmaceutical Industry

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FDA clears Rocket to resume testing gene therapy for a rare heart disease

Rocket's program has been in limbo since early May, when the company surprised investors and analysts with news of the trial's stoppage. That announcement stalled wh...

20 August 2021 news Bluebird | FDA

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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

The U.S. health department's inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investig...

13 August 2021 news Aduhelm | Alzheimer

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In a first, FDA approves an ‘interchangeable’ biosimilar for diabetes

The promise of biosimilars — that competition would bring down the prices of complex biological drugs — hasn't materialized in the U.S. in the way many expected. Comp...

5 August 2021 news ABBVIE | Amgen

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FDA rejects a biotech’s kidney drug, but some analysts still see a ‘sliver of hope’

The FDA's decision wasn't surprising to analysts, as "deficiencies" in an approval application have become somewhat of a prelude to rejection. This year alone saw two...

5 August 2021 news Acadia Pharmaceuticals | Ardelyx

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AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Benlysta's approval was itself a landmark, being the first such drug approved in decades. Its use has grown slowly and steadily over time, falling just shy of blockbu...

5 August 2021 news AstraZeneca | Benlysta

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FDA rejects Insys opioid pain spray

Insys Therapeutics said Friday that the Food and Drug Administration issued it a Complete Response Letter rejecting the company’s New Drug Application for Buvaya. ...

31 July 2018 news FDA | insys

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BIO18: Pfizer (sort of) inches back to neuro; Building ties with FDA

BIO hits its goal Three days into the BIO International convention, the industry group touted breaking the G...

8 June 2018 news BIO | BIO18

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TherapeuticsMD garners FDA OK for Imvexxy

TherapeuticsMD got a green light from the Food and Drug Administration for TX-004HR, a treatment for moderate-to-severe dyspareunia, or vaginal pain during sexual...

1 June 2018 news FDA | Imvexxy

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FDA launches medical device ‘innovation challenge’ to combat opioid crisis

The Food and Drug Administration announced Wednesday an “innovation challenge" aimed at encouraging the development of medical devices such as digital hea...

1 June 2018 news challenge | combat

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Gene Therapies That Could Transform Diseases Get Easier FDA Path

New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by the Food and Drug Administr...

25 May 2018 news diseases | easier

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