FDA Archives - Page 94 of 220

1 minute read

Court Favors Vanda In Case Against FDA Over Detail Disclosure Of Rejection Of Sleep Disorder Drug

March 29, 8:20 AM

A federal court granted final judgment in favor of Vanda Pharmaceuticals Inc’s (NASDAQ:VNDA) Freedom of Information Act (FOIA) case requesting records created…

VNDA

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FDA Removes Partial Clinical Hold From Blueprint Medicines’ Cancer Study

By Vandana Singh

March 29, 6:31 AM

The FDA lifted the partial clinical hold on Blueprint Medicines Corporation’s (NASDAQ:BPMC) Phase 1/2 VELA trial of BLU-222. In February, the agency…

BPMC

2 minute read

Blueprint Medicines Announces Lift Of Partial Clinical Hold On Phase 1/2 VELA Trial Of BLU-222

By Happy Mohamed

March 28, 4:20 PM

Blueprint Medicines Corporation (NASDAQ:BPMC) today announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase 1/2 VELA trial of BLU-222. On February 10, 2023,

BPMC

1 minute read

FDA Sets New Adcomm Date To Review Perrigo’s Oral Contraceptive Pill For OTC Use

By Vandana Singh

March 28, 3:14 PM

The FDA has rescheduled a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic…

PRGO

2 minute read

ARS Pharmaceuticals Announces FDA Advisory Committee For Neffy For The Treatment Of Allergic Reactions, Including Anaphylaxis

By Happy Mohamed

March 28, 9:43 AM

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis,

SPRY

2 minute read

Surmodics Provides Regulatory Update On Its Strategy To Submit An Amended Premarket Approval Application For The Surveil Drug-Coated Balloon

By Happy Mohamed

March 28, 9:41 AM

Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical

SRDX

2 minute read

Short Seller Report On Harmony Biosciences: Here’s Why The Stock Is Tanking

By Vandana Singh

March 28, 9:41 AM

Harmony Biosciences Holdings Inc (NASDAQ: HRMY) shares are trading lower after Scorpion Capital filed a Citizen's Petition with the FDA requesting the withdrawal of approval of Wakix (pitolisant).

HRMY

1 minute read

Athira Pharma Presents Preclinical Data Supporting Therapeutic Potential Of Fosgonimeton For Alzheimer’s And Parkinson’s Diseases At AD/PD 2023 International Conference

By Happy Mohamed

March 28, 1:13 AM

Athira Pharma, Inc. (NASDAQ:ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today presented preclinical data

ATHA

4 minute read