80 news items
Page 2 of 4
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CKPT
22 May 24
that the FDA had issued a complete response letter which "cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party [CMO
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CKPT
21 May 24
issued a complete response letter (‘CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who
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CKPT
20 May 24
a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who
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CKPT
20 May 24
"that the [FDA] has issued a complete response letter (‘CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced
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CKPT
17 May 24
. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA
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CKPT
HRT
OCGN
16 May 24
. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment
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CKPT
16 May 24
or radiation. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA
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CKPT
DERM
FBIO
15 May 24
are not candidates for curative surgery or radiation, in January 2023. In December 2023, the FDA issued a complete response letter ("CRL") for the cosibelimab
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CKPT
15 May 24
, the Company stated that the FDA had issued a complete response letter which "cites findings that arose during a multi-sponsor inspection of Checkpoint's
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CKPT
15 May 24
cSCC who are not candidates for curative surgery or radiation. In particular, the Company announced "that the [FDA] has issued a complete response
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CKPT
13 May 24
a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who
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CKPT
HRT
OCGN
12 May 24
] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced
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CKPT
12 May 24
announced "that the [FDA] has issued a complete response letter (‘CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic
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CKPT
10 May 24
or radiation. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA
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CKPT
FBIO
10 May 24
deficiencies noted in the complete response letter ("CRL") we received from the U.S. Food and Drug Administration ("FDA") last December. Recently, our CMO
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CKPT
8 May 24
, the Company stated that the FDA had issued a complete response letter which "cites findings that arose during a multi-sponsor inspection of Checkpoint's
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CKPT
HRT
OCGN
7 May 24
"that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally
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CKPT
6 May 24
"that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally
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CKPT
6 May 24
a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who
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CKPT
3 May 24
cSCC who are not candidates for curative surgery or radiation. In particular, the Company announced "that the [FDA] has issued a complete response