hNPC01 Fast Track Designation by FDA
As the project partner, BLA congratulates Hopstem Therapeutics on receiving FDA Fast Track Designation for hNPC01 injection– the global first-in-class...
GI-102 Fast Track Designation by FDA
As the project partner, BLA congratulates GI Innovation on receiving FDA Fast Track Designation for GI-102 in immuno-oncology therapy Gaithersburg,...
As the project partner, BLA congratulates BDGene on receiving the EU Orphan Drug Designations for the BD112 project in vivo gene editing therapy despite having only animal model data
As the project partner, BLA congratulates BDGene on receiving the EU Orphan Drug Designations for the BD112 project in vivo...
As the project partner, BLA congratulates Bendao Gene on receiving IND may proceed letter for BD111 project
As the project partner, BLA congratulates Bendao Gene on receiving IND may proceed letter for BD111 project Gaithersburg, MD (July...
As the project Supporter, BLA congratulates Lantern Pharma on receiving IND may proceed letter for LP-184 project
As the project Supporter, BLA congratulates Lantern Pharma on receiving IND may proceed letter for LP-184 project Gaithersburg, MD (June...
As the project Supporter, BLA congratulates Leads Biolabs on receiving IND may proceed letter for LBL-033 project
As the project Supporter, BLA congratulates Leads Biolabs on receiving IND may proceed letter for LBL-033 project Gaithersburg, MD (June...
As the project partner, BLA congratulates Gluetacs Therapeutics on receiving IND may proceed letter for GT919 project
As the project partner, BLA congratulates Gluetacs Therapeutics on receiving IND may proceed letter for GT919 project Gaithersburg,...
As the project partner, BLA congratulates Hangzhou Hanx Biopharmaceuticals on receiving IND may proceed letter for HX009 project
As the project partner, BLA congratulates Hangzhou Hanx Biopharmaceuticals on receiving IND may proceed letter for HX009 project Gaithersburg, MD...
As the project partner, BLA congratulates Deka Bioscienceson receiving IND may proceed letter for DK210 (EGFR) project
As the project partner, BLA congratulates Deka Bioscienceson receiving IND may proceed letter for DK210 (EGFR) project Gaithersburg, MD (February 05,...
As the project partner, BLA congratulates ImmuneOnco on receiving IND may proceed letter for IMM2520 project
As the project partner, BLA congratulates ImmuneOnco on receiving IND may proceed letter for IMM2520 project Gaithersburg, MD (30 December...
As the project partner, BLA congratulates Hangzhou Sumgen Biotech on receiving IND may proceed letter for SG1906 project
As the project partner, BLA congratulates Hangzhou Sumgen Biotech on receiving IND may proceed letter for SG1906 project Gaithersburg, MD...
As the project partner, BLA Regulatory congratulates NKGen Biotech on receiving IND may proceed letter for allogeneic SNK02 project
As the project partner, BLA Regulatory congratulates NKGen Biotech on receiving IND may proceed letter for allogeneic SNK02 project ...
Present at the 3rd Quality Science of Biologics Summit, 12-13 Aug. 2022, Beijing, China
Present at the 3rd Quality Science of Biologics Summit, 12-13 Aug. 2022, Beijing, China Gaithersburg, MD (11 Aug. 2022)...
As the project partner, BLA Regulatory congratulates ImmuneOnco for receiving Fast Track designation from the FDA to IMM2902 for the treatment of HER-2+ breast cancer patients
As the project partner, BLA Regulatory congratulates ImmuneOnco for receiving Fast Track designation from the FDA to IMM2902 for the...
As the regulatory consultant, Dr. Frank Li, congratulates BiOneCure Therapeutics on receiving US FDA IND may proceed letter for BIO-106
As the regulatory consultant, Dr. Frank Li, congratulates BiOneCure Therapeutics on receiving US FDA IND may proceed letter for BIO-106...
BLA Regulatory will present at upcoming Free Senimar on 11 May: Critical Elements of Conducting Early Phase Clinical Trials in the US for APAC Sponsors
BLA Regulatory will present at upcoming Free Senimar on 11 May: Critical Elements of Conducting Early Phase Clinical Trials in...
As the project Supporter, BLA congratulates Immorna on receiving IND may proceed letter for JCXH-211 project
As the project Supporter, BLA congratulates Immorna on receiving IND may proceed letter for JCXH-211 project Gaithersburg, MD (10 April...
Experience from the Human Drug Approval Online Course
Experience from the Human Drug Approval Online Course BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, recently hosted the virtual...
As the project partner, BLA Regulatory congratulates Palleon Pharmaceuticals on receiving US FDA approval of E-602 project IND
As the project partner, BLA Regulatory congratulates Palleon Pharmaceuticals on receiving US FDA approval of E-602 project IND Gaithersburg, MD...
As a partner of Chiauranib/CS2164 project, BLA Regulatory congratulates Chipscreen on receiving US FDA ODD approval
As a partner of Chiauranib/CS2164 project, BLA Regulatory congratulates Chipscreen on receiving US FDA ODD approval Gaithersburg, MD (13 September...
As the project partner, BLA Regulatory congratulates ImmuneOnco on receiving US FDA approval of IMM2902 project IND
As the project partner, BLA Regulatory congratulates ImmuneOnco on receiving US FDA approval of IMM2902 project IND Gaithersburg, MD (25...
As a partner of Chiauranib/CS2164 project, BLA Regulatory congratulates Chipscreen on receiving US FDA IND approval
As a partner of Chiauranib/CS2164 project, BLA Regulatory congratulates Chipscreen on receiving US FDA IND approval Gaithersburg, MD (03 May...
As a partner of CD4B bi-antibody project, BLA Regulatory congratulates I-Mab on receiving US FDA IND approval
As a partner of CD4B bi-antibody project, BLA Regulatory congratulates I-Mab on receiving US FDA IND approval Gaithersburg, MD (03...
2020 End of the Year Summary Report-2 FDA Approved 13 New Large Molecule Drugs and 2 New Gene Therapy Products
2020 End of the Year Summary Report-2 FDA Approved 13 New Large Molecule Drugs and 2 New Gene Therapy Products...
2020 End of the Year Summary Report-1 FDA Approved 38 New Small Molecule Drugs
2020 End of the Year Summary Report-1 FDA Approved 38 New Small Molecule Drugs Download PDF version here. BLA Regulatory,...
Presents at the Cell and Gene Therapy Seminar on 04 Nov. 2020 Shanghai, China
Presents at the Cell and Gene Therapy Seminar on 04 Nov. 2020 Shanghai, China Gaithersburg, MD (28 Oct. 2020) –...
Present at the 2nd Global Biomedicine CDMO Development Forum, 2-3 Nov. 2020, Suzhou, China
Present at the 2nd Global Biomedicine CDMO Development Forum, 2-3 Nov. 2020, Suzhou, China Gaithersburg, MD (26 Oct. 2020) –...