Approved – Page 5

Bayer Receives FDA Approval for Lynkuet, a Novel Non-Hormonal Drug for Menopausal Hot Flashes

3 months ago talkbio0Tagged Approved, Bayer, Elinzanetant, Hot flushes, Lynkuet, Menopause, NK1/NK3 receptors, Non-Hormonal, United States Food and Drug Administration, vasomotor symptom

Bayer; FDA approval; Lynkuet; elinzanetant; hot flashes; menopause; non-hormonal; NK1/NK3 receptors; vasomotor symptoms

FDA Approves Syndax’s First-in-Class Menin Inhibitor with Black-Box Warning; Updates on GSK’s ADC Deal

3 months ago talkbio0Tagged Acute leukemia, Antibody-Drug Conjugates, Approved, black-box warning, Chromosomal translocation, differentiation syndrome, KMT2A gene, Leukemia, Myelocytic, Acute, Menin Inhibitor, oncology drug approval, Revuforj, revumenib, SmithKline Beecham, Syndax, United States Food and Drug Administration

Syndax; Revuforj; revumenib; FDA approval; menin inhibitor; black-box warning; acute leukemia; KMT2A translocation; differentiation syndrome; acute myeloid leukemia (AML); GSK; antibody-drug conjugate (ADC); oncology drug approval

FDA Approves Bayer’s Lynkuet for Menopausal Hot Flashes

3 months ago talkbio0Tagged Approved, Bayer, Hot flushes, Lynkuet, Menopause, United States Food and Drug Administration

FDA approval; Bayer; Lynkuet; menopause; hot flashes

FDA Approves GSK’s Blenrep for Multiple Myeloma Treatment, Marking a Market Return

3 months ago talkbio0Tagged Approved, Blenrep, bortezomib, dexamethasone, Multiple Myeloma, SmithKline Beecham, United States Food and Drug Administration

Blenrep; GSK; FDA Approval; Multiple Myeloma; Bortezomib; Dexamethasone

Replimune Resubmits Melanoma Drug for FDA Approval After Initial Rejection

3 months ago talkbio0Tagged Approved, melanoma, Replimune, resubmission, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; Melanoma Treatment; FDA Approval; Resubmission

Achieve Life Sciences Appoints Erik Atkisson as Chief Legal Officer

3 months ago talkbio0Tagged Achieve Life Sciences, Approved, Chief Legal Officer, cytisine, Erik Atkisson, United States Food and Drug Administration

Achieve Life Sciences; Erik Atkisson; Chief Legal Officer; Cytisinicline; FDA Approval

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

3 months ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

3 months ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

4 months ago talkbio0Tagged Approved, Boehringer Ingelheim, Chronic lung disease, Idiopathic Pulmonary Fibrosis, Jascayd, lung scarring, nerandomilast, Pulmonary Fibrosis, United States Food and Drug Administration

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

4 months ago talkbio0Tagged amgen, Approved, Cardiovascular Diseases, Cardiovascular event, Cerebrovascular accident, LDL-C, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, United States Food and Drug Administration, VESALIUS-CV trial

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke