Sign or Symptom – Talk Bio

FDA Moves to Remove Black Box Warnings from Menopausal Hormone Therapies

2 weeks ago talkbio0Tagged Black Box Warning, estrogens, Hormone replacement therapy, Hormone Therapy, labeling change, Menopausal symptom, Menopause, Progestins, United States Food and Drug Administration, women 's health

FDA; menopause; hormone therapy; black box warning; HRT; estrogen; progestogen; labeling change; women’s health; menopausal symptoms

Expert Flags Potential ‘Honeymoon Effect’ as Rapport Heads Towards Phase III Epilepsy Trials

3 weeks ago talkbio0Tagged Biological Markers, drug-resistant focal seizures, Epilepsy, Honeymoon Effect, KOL Bulletin, mid-stage, Phase 3 Clinical Trials, RAP-219, Rapport Therapeutics, Seizures

KOL Bulletin; honeymoon effect; Rapport Therapeutics; RAP-219; Phase III trials; epilepsy; drug-resistant focal seizures; seizure reduction; mid-stage data; biomarker

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

4 weeks 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 Bayer’s Lynkuet for Menopausal Hot Flashes

4 weeks ago talkbio0Tagged Approved, Bayer, Hot flushes, Lynkuet, Menopause, United States Food and Drug Administration

FDA approval; Bayer; Lynkuet; menopause; hot flashes

Rapport Reveals Promising Phase 2a Data for RAP-219 Epilepsy Pill, Plans Phase 3 Trials

3 months ago talkbio0Tagged anti-seizure medication, Clinical Development, drug-resistant epilepsy, Epilepsy, focal onset seizures, RAP-219, Rapport Therapeutics, Seizures

Rapport Therapeutics; RAP-219; epilepsy; seizure reduction; Phase 2a clinical trial; focal onset seizures; Phase 3 trials; anti-seizure medication; drug-resistant epilepsy; clinical development

Fierce Biotech Fundraising Tracker ’25: CHARM attracts $80M; Wugen reels in $115M

3 months ago talkbio0Tagged AI drug design, charmed, Drug Development, Leukemia, Myelocytic, Acute, Menin Inhibitor, NVIDIA, Series B funding, venture capital, Wugen

CHARM Therapeutics; AI drug design; menin inhibitor; acute myeloid leukemia (AML); Series B funding; venture capital; biotech fundraising; Wugen; NVIDIA; drug development

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

3 months ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

Vertex Drops Next-Generation Pain Drug After Phase 2 Failure, Casts Doubt on Broader Journavx Expansion

4 months ago talkbio0Tagged Acute onset pain, Approved, Drug Development, Journavx, non-opioid pain drugs, Pain management, Peripheral neuropathic pain, Sodium Channel Blockers, United States Food and Drug Administration, VX-993

Vertex Pharmaceuticals; Journavx; VX-993; pain management; acute pain; phase 2 clinical trial; sodium channel inhibitor; non-opioid pain drugs; FDA approval; peripheral neuropathic pain; drug development

Praxis touts ‘best-in-disease’ epilepsy data, but shares dip

4 months ago talkbio0Tagged anti-seizure medication, Clinical Research, Clinical Trials, Epilepsy, focal onset seizures, Market, Praxis Precision Medicines, Radiant heater, Seizures, vormatrigine

Praxis Precision Medicines; epilepsy; vormatrigine; RADIANT study; focal onset seizures; Phase 2 trial; seizure reduction; clinical trial; anti-seizure medication; stock market

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

4 months 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