Governmental or Regulatory Activity – Page 4

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

2 months ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

2 months ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma

FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin

2 months ago talkbio0Tagged Drug Approval, fee structure, Mediation, PDUFA VIII, regulatory policy, United States Food and Drug Administration, user fees

FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations

UnitedHealth Group Names Mike Cotton as New Medicaid CEO in Executive Reshuffle

2 months ago talkbio0Tagged Appointments, Bobby Hunter, CEO, executive changes, Gossypium, government programs, Leadership, Medicaid, UnitedHealth Group

UnitedHealth Group; CEO appointment; Medicaid; Mike Cotton; executive changes; government programs; Bobby Hunter; leadership transition

Alphabet’s Calico Strikes $596M Deal for Mabwell’s Anti-Aging Antibody

3 months ago talkbio0Tagged aging-related diseases, Alphabet, Antibodies, Biopharma, Calico, interleukin-11, Licensing, Mabwell

Calico; Alphabet; Mabwell; anti-aging; biotech; IL-11 antibody; 9MW3811; exclusive licensing; aging-related diseases; biopharma deal

RFK Jr.’s Revamped ACIP Votes Against Thimerosal in Flu Vaccines, Signaling Shift in Vaccine Policy

3 months ago talkbio0Tagged ACIP, Advisory Committees, anti-vaccine movement, Centers for Disease Control and Prevention (U.S.), Immunization, Influenza virus vaccine, Policy, Practice Experience, Respiratory syncytial virus, RFK Jr., thimerosal, Vaccines

RFK Jr.; ACIP; thimerosal; flu vaccine; vaccine policy; anti-vaccine movement; CDC; RSV shot; Advisory Committee on Immunization Practices

Sen. Bill Cassidy Calls for Deferral of CDC Vaccine Meeting After RFK Jr. Panel Shakeup

3 months ago talkbio0Tagged ACIP, Advisory Committees, Bill Cassidy, Centers for Disease Control and Prevention (U.S.), Confirmation, Deferred, HELP Committee, Policy, RFK Jr., Senate, Vaccines

Bill Cassidy; RFK Jr.; CDC; vaccine advisory committee; ACIP; confirmation; deferral; Senate HELP Committee; vaccine policy

Inside the FDA’s Listening Tour: Officials Agree US Lags Behind China on Drug Development

3 months ago talkbio0Tagged Biotechnology, China, Clinical Trials, Drug Development, Drug Industry, innovation, Regulation, United States Food and Drug Administration

FDA; China; drug development; biotechnology; regulation; clinical trials; pharmaceutical industry; biotech innovation

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

3 months ago talkbio0Tagged Accelerated, Biopharma, CNPV, Drug Approval, national priorities, Priority Review, public health medicine (field), Review [Publication Type], United States Food and Drug Administration, unmet

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

3 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment