FDA - International Biopharmaceutical Industry

news

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, a...

11 April 2022 news Akebia | Drug

Continue Reading →

news

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...

1 April 2022 news Akebia | anemia

Continue Reading →

news

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 for A...

1 April 2022 news ALS | Amylyx

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →