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How a long shot ALS drug came before the FDA

The drug's beginnings, according to the two former students there to see them, were quite humble. About a decade ago, Justin Klee and Josh Cohen were undergraduates ...

1 April 2022 news ALS | approval

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Vertex plans path to FDA for top drug prospect

Dive Brief: Vertex will begin late-stage testing of one of its top drug prospects later this month, announcing on Tuesday plans for a Phase 2/3 clinical trial that...

25 March 2022 news Drug | FDA

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FDA, as expected, rejects Lilly and Innovent immunotherapy in signal to drugmakers

Dive Brief: The Food and Drug Administration has rejected an experimental cancer immunotherapy Eli Lilly and partner Innovent Biologics have been developing for a ...

25 March 2022 news drugmakers | Eli Lilly

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FDA panel to review once-rejected Acadia drug for psychosis

Dive Brief: After receiving a rejection last year, Acadia said Wednesday that the Food and Drug Administration agreed to review its resubmitted application to expa...

14 March 2022 news Acadia | Alzheimer

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FDA sets back Karyopharm’s bid to broaden use of cancer drug

Dive Brief: Karyopharm Therapeutics will have to perform a new clinical trial to widen the use of its cancer drug selinexor after U.S. regulators said the results ...

4 March 2022 news cancer | Drug

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Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency

The U.S. Senate on Tuesday voted to confirm Robert Califf as commissioner of the Food and Drug Administration, filling a position that had remained vacant for more th...

18 February 2022 news agency | Califf

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Bristol Myers gets FDA decision date for earlier use of CAR-T therapy

Dive Brief: The Food and Drug Administration will decide whether to approve Bristol Myers Squibb's cancer cell therapy Breyanzi for earlier use by late June, the c...

18 February 2022 news Bristol | CAR-T

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Why the FDA is making a test case of a cancer drug from China

At a quick glance, the Food and Drug Administration's decision to ask its advisers for help in vetting yet another cancer immunotherapy may seem odd. After all, the ...

10 February 2022 news cancer | china

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Lilly slows FDA submission of Alzheimer’s drug after Medicare decision

Dive Brief: Eli Lilly is pushing back the timing for when it expects to finish submitting an application for U.S. approval of its experimental drug for Alzheimer's...

6 February 2022 news Alzheimer | Drug

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A biotech wins the first FDA drug approval in a rare type of eye cancer

Dive Brief: The Food and Drug Administration on Tuesday granted approval to the first drug for a rare cancer of the eye that has spread elsewhere or grown too larg...

27 January 2022 news Biotech | cancer

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How a long shot ALS drug came before the FDA

Vertex plans path to FDA for top drug prospect

FDA, as expected, rejects Lilly and Innovent immunotherapy in signal to drugmakers

FDA panel to review once-rejected Acadia drug for psychosis

FDA sets back Karyopharm’s bid to broaden use of cancer drug

Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency

Bristol Myers gets FDA decision date for earlier use of CAR-T therapy

Why the FDA is making a test case of a cancer drug from China

Lilly slows FDA submission of Alzheimer’s drug after Medicare decision

A biotech wins the first FDA drug approval in a rare type of eye cancer

International Biopharmaceutical Industry