Qualitative Concept – Page 2

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

1 week 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 weeks 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

AstraZeneca’s Baxdrostat Achieves Pivotal Phase 3 Success for Hypertension, Validating $1.3B CinCor Acquisition

2 weeks ago talkbio0Tagged Acquisition, AstraZeneca, baxdrostat, CinCor Pharma, Clinical Trials, Hypertensive disease, treatment-resistant hypertension, Uncontrolled

AstraZeneca; baxdrostat; CinCor Pharma; hypertension; high blood pressure; phase 3 trial; aldosterone synthase inhibitor; $1.3 billion acquisition; clinical trial win; uncontrolled hypertension; treatment-resistant hypertension

FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues

2 weeks ago talkbio0Tagged Approved, gene therapy, manufacturing issues, Mucopolysaccharidosis Type IIIA, Regulatory Setback, Response Letter, Ultragenyx, United States Food and Drug Administration, UX111

FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay

WHO to Develop Guidelines for Gilead’s Twice-Yearly HIV PrEP Injection (Lenacapavir)

2 weeks ago talkbio0Tagged Approved, Gilead, Guidelines, HIV Prevention, Lenacapavir, PREP gene, twice-yearly injection, United States Food and Drug Administration, World Health Organization

WHO; Gilead; Lenacapavir; twice-yearly injection; PrEP; HIV prevention; guidelines; FDA approval

Bayer’s Lynkuet (elinzanetant) Wins First-in-World Approval in UK, Challenging Astellas’ Hot Flash Drug

2 weeks ago talkbio0Tagged Approved, Astellas, Bayer, Elinzanetant, Hot flushes, Lynkuet, Menopause, MHRA, non-hormonal therapy, UK, vasomotor symptom

Bayer; elinzanetant; Lynkuet; menopause; hot flashes; vasomotor symptoms; Astellas; non-hormonal therapy; MHRA approval; UK first approval

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

2 weeks ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children

2 weeks ago talkbio0Tagged Approved, At-Risk, Child, conditions, Covid Vaccine, Moderna, Spikevax, United States Food and Drug Administration

Moderna; FDA approval; COVID vaccine; children; at-risk; Spikevax; underlying conditions; full approval

Novartis Gains World-First Approval of Malaria Treatment for Babies

2 weeks ago talkbio0Tagged Africa, Approved, artemether-lumefantrine, Coartem, Infant, Infant, Newborn, Malaria, Novartis, Swissmedic, venture

Novartis; malaria; Coartem Baby; Swissmedic; newborns; infants; Africa; approval; artemether-lumefantrine; Medicines for Malaria Venture; not-for-profit

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

4 weeks ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference