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published : This year    tags : Fda    save search

FDA Requires Boxed Warning for Secondary Cancers on CAR-T Therapies
Published: 2024-04-19 (Crawled : 12:00) - biospace.com/
JNJ | News | $147.91 1.49% -0.03% 9.6M twitter stocktwits trandingview |
Health Technology
| | O: 0.83% H: 1.35% C: 1.2%

fda for car-t
U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
Published: 2024-04-18 (Crawled : 23:00) - biospace.com/
TAK | News | $13.24 0.61% 0.0% 1.3M twitter stocktwits trandingview |
Health Technology
| | O: 0.0% H: 0.0% C: 0.0%

entyvio fda disease active for therapy
Teva, Alvotech Secure FDA Approval for Stelara Biosimilar with Early 2025 Launch
Published: 2024-04-18 (Crawled : 14:00) - biospace.com/
JNJ | News | $147.91 1.49% -0.03% 9.6M twitter stocktwits trandingview |
Health Technology
| | O: 0.12% H: 0.0% C: 0.0%

fda biosimilar approval for stelara
Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
Published: 2024-04-16 (Crawled : 21:00) - globenewswire.com
JNJ | News | $147.91 1.49% -0.03% 9.6M twitter stocktwits trandingview |
Health Technology
| | O: -0.04% H: 0.28% C: -0.16%

stelara fda biosimilar approval teva
Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil)
Published: 2024-04-16 (Crawled : 16:00) - biospace.com/
PTPI | $0.6849 -1.86% -1.9% 150K twitter stocktwits trandingview |
| | O: 9.85% H: 4.63% C: -18.04%

fda positive pharmaceuticals for technology response
BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
Published: 2024-04-16 (Crawled : 12:00) - globenewswire.com
BRTX | $1.39 -3.47% -3.6% 160K twitter stocktwits trandingview |
Professional, Scientific, and T...
| | O: 9.23% H: 15.49% C: -7.75%

brtx-100 fda clearance study
Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy
Published: 2024-04-16 (Crawled : 12:00) - globenewswire.com
LXEO | $11.995 -0.62% -0.63% 87K twitter stocktwits trandingview |
| | O: 5.32% H: 0.0% C: -2.63%

lx2006 fda candidate granted treatment designation for therapeutics therapy
UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Published: 2024-04-15 (Crawled : 13:00) - biospace.com/
URGN | $13.78 -3.37% -3.48% 390K twitter stocktwits trandingview |
Health Technology
| | O: 1.46% H: 1.17% C: -1.44%

ugn-103 fda drug bladder cancer for application
FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection
Published: 2024-04-15 (Crawled : 13:00) - biospace.com/
SNGX | $0.4233 -2.76% -2.83% 1M twitter stocktwits trandingview |
Health Technology
| | O: 75.34% H: 37.73% C: -30.58%

fda drug marburg infection designation for grants
Reviva Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia
Published: 2024-04-15 (Crawled : 13:00) - globenewswire.com
RVPH | $3.035 0.5% 0.49% 140K twitter stocktwits trandingview |
| | O: -7.05% H: 4.96% C: 1.46%

fda brilaroxazine trials for schizophrenia
3D Systems Announces FDA Clearance for World’s First 3D-Printed PEEK Cranial Implants
Published: 2024-04-15 (Crawled : 13:00) - globenewswire.com
DDD F | $3.55 2.31% 0.0% 1.5M twitter stocktwits trandingview |
Producer Manufacturing
| | O: 5.95% H: 0.26% C: -9.95%

fda first clearance for
TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors
Published: 2024-04-15 (Crawled : 13:00) - globenewswire.com
RNAZ | $0.49 -2.39% -2.45% 110K twitter stocktwits trandingview |
Professional, Scientific, and T...
| | O: 0.11% H: 5.95% C: -13.78%

mc138 fda ttx-mc138 tumors clearance trial therapeutics advanced
FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Sudan Ebolavirus Infection
Published: 2024-04-11 (Crawled : 20:00) - biospace.com/
SNGX | $0.4233 -2.76% -2.83% 1M twitter stocktwits trandingview |
Health Technology
| | O: 3.67% H: 0.46% C: -19.02%

fda drug infection designation for grants
Candel Therapeutics Receives FDA Orphan Drug Designation for CAN-2409 for the Treatment of Pancreatic Cancer
Published: 2024-04-11 (Crawled : 13:00) - globenewswire.com
CADL | $5.17 -5.31% -5.61% 520K twitter stocktwits trandingview |
| | O: 25.49% H: 23.75% C: 13.75%

can-2409 fda drug cancer pancreatic treatment designation for therapeutics
PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers
Published: 2024-04-11 (Crawled : 12:00) - biospace.com/
PTCHF | $2.78 19.97% 560 twitter stocktwits trandingview |
n/a
| | O: 4.65% H: 0.0% C: 0.0%

lyt-200 fda designation for
Oncolytics Biotech® Advances Toward Registration-Enabling Trial for Pelareorep in Breast Cancer with Submission of Type C Meeting Request to FDA
Published: 2024-04-11 (Crawled : 12:00) - biospace.com/
ONCY | $1.045 -3.24% -3.35% 180K twitter stocktwits trandingview |
Health Technology
| | O: 1.85% H: 0.0% C: 0.0%

biotech fda breast cancer for meeting trial submission
Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis
Published: 2024-04-11 (Crawled : 05:00) - globenewswire.com
LLY | News | $726.31 -2.63% -0.04% 3.5M twitter stocktwits trandingview |
Health Technology
| | O: 1.06% H: 0.47% C: -0.03%

fda device disease test granted blood designation for alzheimer's roche
Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit
Published: 2024-04-10 (Crawled : 12:00) - biospace.com/
LH M | $201.48 1.02% 0.0% 770K twitter stocktwits trandingview |
Health Services
| | O: -0.9% H: 0.0% C: 0.0%

fda test authorization for home labcorp
Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma
Published: 2024-04-09 (Crawled : 12:30) - globenewswire.com
LSTA | $2.85 -5.82% 2K twitter stocktwits trandingview |
Manufacturing
| | O: 0.34% H: 9.62% C: 3.78%

fda drug granted treatment designation for therapeutics
Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression
Published: 2024-04-09 (Crawled : 12:00) - biospace.com/
SYRS | $4.54 -3.81% -3.96% 260K twitter stocktwits trandingview |
Health Technology
| | O: 2.16% H: 23.21% C: 16.03%

fda treatment designation for aml
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