Organization – Page 5

FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts

4 months ago talkbio0Tagged Agencies, Approved, Impact food supplement, PDUFA, questions, United States Food and Drug Administration

United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions

FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill

4 months ago talkbio0Tagged Accelerated, Agencies, Artificial Intelligence, Califf, Contraceptives, Oral, Infrequent, RIFs, United States Food and Drug Administration, Unspecified Abortion

United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies

Caribou cuts 32% of staff, further purges pipeline to focus on 2 oncology CAR-T prospects

5 months ago talkbio0Tagged 32%, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, CAR-T, Cell Therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, Neoplasms, Reindeer, Staff, United States Food and Drug Administration

Reindeer, CAR-T, Staff, Neoplasms, Cell Therapy, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, United States Food and Drug Administration, 32%

Halozyme sues Merck over subcutaneous Keytruda as licensing talks fall through

5 months ago talkbio0Tagged Halozyme, Legal patent, Merck, Subcutaneous Keytruda

Merck, Legal patent, Subcutaneous Keytruda, Halozyme

Thermo Fisher jumps on the US investment bandwagon with $2B in additional spending

5 months ago talkbio0Tagged development aspects, Investments, Manufacture, Martes pennanti, Science, Thermo Fisher, United States

United States, Investments, Manufacture, Martes pennanti, Science, development aspects, Thermo Fisher

Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations

5 months ago talkbio0Tagged CEOs, EU, Financial cost, Investments, Market, nations, Novartis, Parity, Pharma, Prices, sanofi, Transplant Registry Unified Management Program, U.S.

EU, Novartis, CEOs, Transplant Registry Unified Management Program, Financial cost, Parity, sanofi, Investments, Prices, Pharma, Market, nations, U.S.