fda rejection letters

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FDA publishes rejection letters sent to drugmakers

FDA Will Share Rejection Letters Drugmakers Often Conceal

The US Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their drugs were rejected, detailing information that until now has mostly been hidden from investors and the public.

Fierce Biotech · 1d

FDA releases ‘initial batch’ of more than 200 drug rejection letters

· 1d · on MSN

US FDA publishes 200 rejection letters in transparency push

19h

F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

Fierce Pharma2h

‘Weak evidence’ and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

BioSpace3h

Capricor Plunges on FDA Rejection of DMD Cell Therapy

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

48m

FDA funding clash looms between Senate, House

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

Indianapolis Business Journal1d

FDA begins sharing rejection letters drugmakers often kept secret

Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.

STAT1d

Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more

A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

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