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tags : Fda save search
Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC
Published: 2024-02-29 (Crawled : 13:30) - globenewswire.com
ICPT | $19.0 -0.05% 4M
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ocaliva fda drug treatment application
CytoDyn Announces FDA Has Lifted Clinical Hold
Published: 2024-02-29 (Crawled : 13:30) - globenewswire.com
CYDY | $0.146 -1.35% 0.06% 0
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fda lifted
Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission
Published: 2024-02-29 (Crawled : 13:00) - globenewswire.com
ACHV | $4.57 4.34% 4.37% 53K
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fda life sciences agreement submission
Inhibikase Therapeutics Announces Full Outcomes of its Pre-NDA Meeting with the FDA for IkT-001Pro
Published: 2024-02-28 (Crawled : 21:00) - globenewswire.com
IKT | $2.13 0.19% 0.19% 1
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fda meeting therapeutics
Femasys’ FemaSeed FDA Clearance Brings Timely Access to a First-Line Infertility Treatment Option as an Alternative to IVF
Published: 2024-02-28 (Crawled : 14:00) - globenewswire.com
FEMY | $1.3 -0.76% -1.16% 110K
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fda femaseed treatment clearance alternative
Intelligent Bio Solutions Partners with Cliantha Research to Conduct Clinical Study as Part of FDA 510(k) Pathway
Published: 2024-02-28 (Crawled : 13:30) - globenewswire.com
INBS | $2.68 -8.84% -11.36% 86K
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fda research solutions study
Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
Published: 2024-02-28 (Crawled : 13:00) - globenewswire.com
APLT A | $4.83 -6.21% -6.85% 860K
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fda drug review treatment application therapeutics
FDA Decisions: Allecra Succeeds Where Competitors Failed; Another Humira Copycat
Published: 2024-02-27 (Crawled : 15:00) - biospace.com/
PRGO | $30.04 0.27% 0.97% 650K
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JNJ | News | $144.77 0.22% 0.22% 7.9M
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ABT | News | $105.9 -3.03% 0.38% 11M
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fda humira
Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dystrophy
Published: 2024-02-27 (Crawled : 13:30) - globenewswire.com
CAPR | $5.55 -6.41% -6.46% 470K
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cap-1002 fda meeting commercial therapeutics duchenne
Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
Published: 2024-02-27 (Crawled : 13:00) - globenewswire.com
NERV | $2.47 -1.2% -3.73% 16K
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fda drug treatment schizophrenia application roluperidone response negative
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520
Published: 2024-02-27 (Crawled : 13:00) - biospace.com/
NUVL | $64.25 -0.77% -0.89% 590K
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nvl-520 fda designation therapy
Theratechnologies Receives Refusal to File Letter for Trogarzo® Intramuscular Method of Administration sBLA from FDA
Published: 2024-02-27 (Crawled : 12:30) - globenewswire.com
THTX | $1.32 3.13% -12.78% 9.6K
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trogarzo fda
Acurx Announces FDA Has Granted an End of Phase 2 Meeting for Ibezapolstat for C. difficile Infection and the European Medicines Agency Granted SME Designation for Ibezapolstat EU Development
Published: 2024-02-27 (Crawled : 12:00) - prnewswire.com
ACXP | $1.8 8.43% 7.78% 1.5K
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fda granted ibezapolstat infection designation meeting
BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA
Published: 2024-02-27 (Crawled : 12:00) - biospace.com/
BGNE S | $131.86 -1.63% -1.64% 3
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tevimbra fda license application
U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
Published: 2024-02-27 (Crawled : 01:00) - globenewswire.com
GNMSF | $281.02 -1.44% 3.83% 0
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ABBV | $164.25 1.05% 0.26% 3M
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GMAB | $28.53 -3.06% -3.23% 1.3K
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epkinly fda license review application
MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)
Published: 2024-02-26 (Crawled : 13:00) - globenewswire.com
MLTX | $43.51 0.02% 0.06% 270K
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SNYNF | News | $92.7 0.63% -2.18% 1.4K
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SNY | News | $46.11 0.68% 0.7% 3.5M
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nanobody fda positive ema program
FDA Roundup: February 23, 2024
Published: 2024-02-23 (Crawled : 23:00) - fda.gov
FNCTF | News | $11.0354 -0.83% -20.84% 34K
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FDA Decisions: CMC Issues Thwart Venatorx and Melinta’s Urinary Tract Infecti...
Published: 2024-02-23 (Crawled : 21:00) - biospace.com/
PRGO | $30.04 0.27% 0.97% 650K
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JNJ | News | $144.77 0.22% 0.22% 7.9M
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ABT | News | $105.9 -3.03% 0.38% 11M
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SNY | News | $46.11 0.68% 0.7% 3.5M
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fda
FDA Decisions: CMC Issues Thwart Venatorx and Melinta’s Urinary Tract Infection Antibiotic
Published: 2024-02-23 (Crawled : 19:00) - biospace.com/
PRGO | $30.04 0.27% 0.97% 650K
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JNJ | News | $144.77 0.22% 0.22% 7.9M
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ABT | News | $105.9 -3.03% 0.38% 11M
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SNY | News | $46.11 0.68% 0.7% 3.5M
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fda infection
Sanofi, Regeneron Secure FDA Priority Review for Dupixent in COPD
Published: 2024-02-23 (Crawled : 15:00) - biospace.com/
SNY | News | $46.11 0.68% 0.7% 3.5M
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fda dupixent review copd
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SRFM 4 | $0.3859 -12.3% 23.84% 660K
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