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approvals

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that …

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COVID-19

FDA places stricter limits on J&J’s COVID-19 vaccine after review of rare side effect

Dive Brief: The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 …

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Amgen

FDA sets back Novartis’ best chance at a COVID-19 drug

Dive Brief: Novartis is reevaluating its commitment to an experimental COVID-19 treatment originally developed by fellow Swiss drug company Molecular Partners after the Food and …

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blood

FDA panel supports agency push to raise approval bar for certain cancer drugs

The Food and Drug Administration appears ready to raise its approval standards for a well-known class of cancer drugs due to concerns they aren’t helping …

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cancer

FDA clears Gilead to restart some studies of top cancer drug

Dive Brief: The Food and Drug Administration has cleared Gilead to restart some trials testing an experimental cancer drug the company acquired in a roughly …

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COVID-19

FDA advisers grapple with how to update COVID-19 vaccines

A group of advisers to the Food and Drug Administration agreed Wednesday that COVID-19 vaccines will likely need to be updated to keep pace with …

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Akebia

Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection

Dive Brief: Akebia Therapeutics will lay off 42% of its workforce after the Food and Drug Administration last month rejected its most advanced experimental drug, …

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Akebia

FDA rejects Akebia drug, dealing another blow to anemia pills

Dive Brief: The Food and Drug Administration rejected an Akebia Therapeutics’ anemia pill vadadustat, the company announced Wednesday, over concerns the drug isn’t as safe as currently …

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ALS

FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine …

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ALS

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 …

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Drug

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 …

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drugmakers

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 common …

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Acadia

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 expand …

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cancer

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 …

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agency

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 …

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Bristol

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, …

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cancer

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. …

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Alzheimer

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 …

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Biotech

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 …

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cancer

Incyte withdraws cancer drug from FDA review after discussions with regulator

Dive Brief: Incyte is pulling its application for an experimental lymphoma medicine after determining that the Food and Drug Administration’s requirements for confirmatory studies would …

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