Tag: Biologics license application

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Recent Related Articles to Biologics license application

FDA Deviated From Normal Process in Pfizer Vaccine Approval, Documents Show

Added to Collection on: 2023-01-07 16:44:35

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Health
Food and Drug Administration
Articles
Biologics license application
Pfizer
Vaccine
United States

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USFDA issues CRL for proposed biosimilar Insulin-R: Biocon - Newsdrum

Added to Collection on: 2023-01-07 21:22:37

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Life Sciences
Articles
Health
Biotechnology
Biocon
Companies based in Bangalore
Food and Drug Administration
Pharmaceutical industry
Biopharmaceutical
Biologics license application
BLA
CRL
Biocon Ltd
Biocon Biologics

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Safety Outcomes When “Switching” Between Biosimilars and Reference Products | FDA

Added to Collection on: 2023-12-05 22:20:59

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Pharmaceutical industry
Biotechnology products
Specialty drugs
Monoclonal antibodies
Immunosuppressants
Biosimilar
Biopharmaceutical
Biologics license application
Biologics Price Competition and Innovation Act
Association for Accessible Medicines
Adalimumab

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FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara ...

Added to Collection on: 2024-01-06 02:31:09

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Biotechnology products
Pharmaceutical industry of Gujarat
Intas Pharmaceuticals
Healthcare in India
Biopharmaceutical
Ustekinumab
Accord
Pharmaceutical industry in India
Meiji Seika Pharma
Biologics license application
Intas Pharmaceuticals Ltd.
United States
Stelara
Accord BioPharma Inc.

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Astellas Provides Update on Zolbetuximab Biologics License Application in U.S. | Antibodies

Added to Collection on: 2024-01-09 15:19:16

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Food and Drug Administration
Astellas Pharma
Mitsubishi UFJ Financial Group
Monoclonal antibodies
Zolbetuximab
CLDN18
Prescription Drug User Fee Act
Biologics license application
u.s. food and drug administration
Astellas Pharma Inc.

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Biologics Market Worth USD 717.0 Billion From 2024 to 2031 | BioSpace

Added to Collection on: 2024-05-06 13:46:26

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Biotechnology products
Pharmacy
Biotechnology
Biopharmaceuticals
Pharmaceutical industry
Biosimilar
Novartis
Samsung Biologics
Eli Lilly and Company
Food and Drug Administration
Pharmaceutical industry in India
Biologics license application

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FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Added to Collection on: 2024-06-12 17:22:48

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Food and Drug Administration
Biotechnology products
Drug safety
Drug development
Clinical research
New Drug Application
Center for Biologics Evaluation and Research
Biologics license application
Investigational New Drug
Biopharmaceutical
Approved drug
Fast track

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Humacyte Announces FDA Communication of Additional Time Required to Complete ... - Stock Titan

Added to Collection on: 2024-08-10 08:17:50

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Food and Drug Administration
Prescription Drug User Fee Act
PDUFA date
Priority review
Biologics license application
humacyte, inc.
Ukraine

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CMS Assigns Reimbursement Code for Investigative Cell Therapy

Added to Collection on: 2024-08-13 16:21:54

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Genodermatoses
Collagen disease
Epidermolysis bullosa dystrophica
Biologics license application
Epidermolysis bullosa
Food and Drug Administration
the centers for medicare and medicaid services

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FDA Accepts GSK's Biologics License Application of Blenrep for Relapsed or Refractory ...

Added to Collection on: 2024-12-02 19:42:08

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Orphan drugs
Multiple myeloma
Pomalidomide
Bortezomib
Belantamab mafodotin
Dexamethasone
Monomethyl auristatin F
Biologics license application
Daratumumab/hyaluronidase
Elotuzumab

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