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Top stories

FDA Drops Advisory Panel for Biohaven Spinocerebellar Ataxia Drug Review

FDA Drops Advisory Panel for Biohaven Spinocerebellar Ataxia Drug Review

Authors

5

1 year ago

BioXcel Therapeutics Reports Positive FDA Pre-sNDA Feedback, Locks SERENITY Phase 3 Database, Shares Up 27%

BioXcel Therapeutics Reports Positive FDA Pre-sNDA Feedback, Locks SERENITY Phase 3 Database, Shares Up 27%

Authors

6

1 year ago

BioXcel’s BXCL501 Passes Phase 3 Safety Trial for At-Home Agitation Care

BioXcel’s BXCL501 Passes Phase 3 Safety Trial for At-Home Agitation Care

Authors

7

1 year ago

Cognition Therapeutics, Cel-Sci Sell Shares as Celcuity Pushes Breast-Cancer NDA

Authors

3

1 year ago

FDA Grants Breakthrough Therapy to PTGX’s Rusfertide for Erythrocytosis in Polycythemia Vera; NDA Filing Q4 2025, Quest Diagnostics Receives Breakthrough Device Designation

Authors

5

1 year ago

FDA Actions Lift Soligenix 44% and BioXcel 27% in U.S. Premarket

Authors

10

1 year ago

Prediction markets for New Drug Application

Outcomes of Eli Lilly's attempt to get retatrutide classified as a biologic vs. a regular drug?

Oct 24, 1:32 AMDec 31, 11:59 PM

341

OptionProbability

Lilly files a Biologics License Application (BLA) for retatrutide

Lilly files a standard New Drug Application (NDA) for retatrutide

FDA rejects biologics license application for retatrutide

7th Circuit rules that retatrutide DOES count as a biologic

FDA approves retatrutide as a biologic

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Latest stories

Latest stories

Aug 28, 2025
Aug 28, 2025
Stocks
Pharma
Business
Cognition Therapeutics, Cel-Sci Sell Shares as Celcuity Pushes Breast-Cancer NDA
Authors
3
1 year ago
Aug 27, 2025
Aug 27, 2025
Health
Pharma
Science
BioXcel’s BXCL501 Passes Phase 3 Safety Trial for At-Home Agitation Care
Authors
7
1 year ago
Aug 25, 2025
Aug 25, 2025
Health
Pharma
Science
FDA Grants Breakthrough Therapy to PTGX’s Rusfertide for Erythrocytosis in Polycythemia Vera; NDA Filing Q4 2025, Quest Diagnostics Receives Breakthrough Device Designation
Authors
5
1 year ago
Aug 22, 2025
Aug 22, 2025
Stocks
Pharma
Business
FDA Drops Advisory Panel for Biohaven Spinocerebellar Ataxia Drug Review
Authors
5
1 year ago
Aug 19, 2025
Aug 19, 2025
Stocks
Bio
Pharma
BioXcel Therapeutics Reports Positive FDA Pre-sNDA Feedback, Locks SERENITY Phase 3 Database, Shares Up 27%
Authors
6
1 year ago
Aug 18, 2025
Aug 18, 2025
Stocks
Pharma
Business
FDA Actions Lift Soligenix 44% and BioXcel 27% in U.S. Premarket
Authors
10
1 year ago

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