FDA Archives - Page 141 of 220

5 minute read

Takeda’s Biologics License Application For Dengue Vaccine Candidate, TAK-003, Granted Priority Review By U.S. FDA

November 22, 4:58 PM

- TAK-003 is Being Evaluated for the Prevention of Dengue Disease Caused by Any Dengue Virus Serotype in Individuals 4 Years Through 60 Years of Age Takeda ((TAK) today announced that the U.S. Food and Drug

TAK

1 minute read

‘Synlogic Gets FDA Orphan Drug Designation For Live Biotherapeutic For Treatment Of Homocystinuria’ – FDA

By Benzinga Newsdesk

November 22, 4:51 PM

Search Orphan Drug Designations and Approvals (fda.gov)

SYBX

1 minute read

FDA
News

AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline At The 64th ASH Annual Meeting

By Benzinga Newsdesk

November 22, 4:47 PM

- Nearly 65 abstracts, including 15 oral presentations on 7 investigational and approved medicines across 8 cancer types, to be presented at the American Society of Hemaotology

ABBV

1 minute read

Lucira Health Gets FDA Emergency Use Authorization For Its Combined Covid-19/Flu Test

By Benzinga Newsdesk

November 22, 4:21 PM

Lucira- COVID-19 & Flu Test-Letter of Authorization (fda.gov)

LHDX

1 minute read

FDA
News

Novartis Highlights Advances With Kisqali, Iptacopan, Scemblix And YTB323 Data At SABCS And Ash

By Benzinga Newsdesk

November 22, 10:28 AM

First data to be presented as a late-breaker abstract from global pivotal APPLY-PNH trial of investigational oral monotherapy iptacopan in paroxysmal nocturnal hemoglobinaria (PNH), a rare and serious

NVS

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FDA
News

Cel-Sci Corp Says Phase 3 Trial Showed Multikine Immunotherapy Extended Lives Of Patients With Locally Advanced Primary SCCHN

By Benzinga Newsdesk

November 22, 10:09 AM

CEL-SCI Corporation (NYSE:CVM) today issued a letter to its shareholders. Dear CEL-SCI Shareholders: I wanted to write to update you on our progress. Our story is following the well-worn path of all

CVM

4 minute read

Jack Ma’s Ant Group Slapped With $1B Fine, Carl Icahn’s Huge Short Position In GameStop, Novavax Culls COVID-19 Vaccine Alliance With GAVI: Top Stories Tuesday, Nov. 22

By Vandana Singh

November 22, 10:00 AM

Reuters

AMZN

2 minute read

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating Its Lead Compound, OmnImmune, In Patients With Acute Myeloid Leukemia

By Benzinga Newsdesk

November 22, 9:12 AM

3 Patients Dosed in 5 Patient Safety Cohort EDINBURGH, Scotland, Nov. 22, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ:TCBP)

TCBP

7 minute read

Argenx Announces U.S. FDA Acceptance Of Biologics License Application For Subcutaneous Efgartigimod In Generalized Myasthenia Gravis With Priority Review; PDUFA Date Is March 20, 2023

By Benzinga Newsdesk

November 22, 2:05 AM

- Prescription Drug User Fee Act (PDUFA) target action date is March 20, 2023 - Submission based on positive results from the Phase 3 bridging study demonstrating noninferior total IgG reduction at day

ARGX

2 minute read

Gamida Cell Provides Regulatory Update On Omidubicel, Says Received Extension Of Omidubicel PDUFA Date From Jan. 30, 2023 To May 1, 2023 As FDA Issued Information Request

By Michael Horton

November 21, 5:54 PM

Gamida Cell Ltd. (NASDAQ:GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and solid cancers and other serious diseases, today provided an update on recent

GMDA