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Why coherus biosciences stock popped today

Coherus announced it has resubmitted a biologic license application for one of its products. The FDA ha...

October 5, 2023, 4:45 pm

60 degrees pharma withdraws covid phase iib ind, will resubmit pending assessment of ability to meet fda requirements

Prompted by advice from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of 60 Degrees Pharmaceuticals, has withdrawn it...

September 18, 2023, 8:16 pm

Valkyrie refiles bitcoin etf application amid crypto optimism

Valkyrie has become the latest issuer to resubmit an application for a Bitcoin exchange-traded fund aft...

July 5, 2023, 10:59 pm

Blackrock refiles for bitcoin etf, after sec reportedly deemed previous filing inadequate

BlackRock, the world’s largest asset manager, resubmits filing through Nasdaq to include new details ...

July 4, 2023, 12:29 am

Blackrock’s bitcoin etf application resubmitted by nasdaq to sec

Nasdaq has resubmitted its application to the U.S. Securities and Exchange C (SEC) to list a bitcoin ex...

July 3, 2023, 11:14 pm

Bitcoin price stagnates at $30k as etf applicants resubmit applications in asian market

The Bitcoin price has encountered a period of stagnation, hovering at $30K as ETF applicants resubmit a...

July 3, 2023, 8:45 pm

Fidelity officially submits its spot bitcoin etf application

Fidelity has joined the other US companies to resubmit its application for a Bitcoin spot exchange-trad...

June 30, 2023, 8:28 am

Mesoblast's (meso) gvhd drug bla gets fda priority tag, stock up

Mesoblast (MESO) announces the FDA acceptance for review of the resubmitted biological license applicat...

March 9, 2023, 8:24 am

Ardelyx regulatory catalyst looms in april, but invest in it longer

Ardelyx's sole marketed drug can't keep the company afloat by itself until it gets broader insurance coverage. The company is ...

March 6, 2023, 8:00 am

Phathom's stock falls after receiving fda letters

Shares of Phathom Pharmaceuticals Inc. PHAT, -0.60% tumbled about 23% in premarket trading on Friday, the day after the company said it received compl...

February 10, 2023, 7:59 am

Intercept resubmits new drug application to u.s. fda for obeticholic acid in patients with liver fibrosis due to nash

NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes deta...

December 23, 2022, 12:50 pm

Gilead (gild) resubmits nda for hiv inhibitor to the fda

Gilead (GILD) announces the resubmission of the NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-...

June 28, 2022, 10:04 am

Acadia (acad) up on fda briefing document for nuplazid snda

The FDA issues briefing documents related to Acadia's (ACAD) resubmitted sNDA for Nuplazid for treating...

June 16, 2022, 12:20 pm

Why acadia pharmaceuticals shares are trading higher today?

Ahead of Acadia Pharmaceuticals Inc's (NASDAQ: ACAD) FDA AdComm meeting on Friday, the agency officials released their briefing documents, reveali...

June 15, 2022, 3:07 pm

Pfizer resubmits application for covid-19 vaccine for children under 5

The FDA is meeting on June 15 to discuss emergency use authorization....

June 1, 2022, 8:15 pm

Outlook therapeutics opts to resubmit bla for wet amd drug after fda requests more info

Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bev...

May 31, 2022, 10:26 am

Zosano pharma announces additional workforce layoff

The FDA had granted Zosano Pharma Corporation (NASDAQ: ZSAN) a twelve-month extension to April 20, 2023, to ...

May 2, 2022, 9:25 am

Acadia (acad) stock up on fda's action date for nuplazid snda

Acadia (ACAD) gets an action date of Aug 4, 2022, from the FDA for its resubmitted sNDA for pimavanseri...

March 10, 2022, 1:32 pm

Orphazyme (orph) up on plans of nda resubmission for rare drug

Orphazyme (ORPH) is looking to resubmit its NDA for arimoclomol to the FDA for the treatment of Niemann...

February 14, 2022, 1:56 pm

Orphazyme (orph) up on plans of nda resubmission for rare drug

Orphazyme (ORPH) is looking to resubmit its NDA for arimoclomol to the FDA for the treatment of Niemann...

February 14, 2022, 1:56 pm


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