FDA_Alerts

Will FDA approve? 🟢 Yes / 🔴 No — drop your take 👇 RT tweet 1 if this helped 🙏 #FDA #PDUFA #Biotech #VSTM #OvarianCancer #LGSOC #BiotechTwitter

📊 Why LGSOC is so underserved: • ~3,000 US cases/yr — 15-20% of epithelial ovarian cancers • Younger patients (avg ~45 yrs) — years of life at stake • Platinum-resistant, chemo-insensitive • ~60% harbor RAS/MAPK mutations ripe for targeting

🚨🧬 THREAD: $VSTM's avutometinib+defactinib faces FDA decision on May 22. Low-grade serous ovarian cancer has had ZERO approved targeted therapies — until now. Here's why this matters 🧵👇

Will FDA approve linvoseltamab? 🟢 Yes / 🔴 No — drop your take 👇 RT tweet 1 if this helped 🙏 cc: @Regeneron #FDA #PDUFA #MultipleMyeloma #Biotech #REGN #Myeloma #BiotechTwitter

💊 Multiple myeloma kills ~12,000 Americans/year. Late-line patients exhaust 4+ drug classes fast — and run out of options. Linvoseltamab targets that exact group: 64% response even when everything else has failed. Peak US sales estimates: $700M–$1B+

🚨🧬 THREAD: $REGN's linvoseltamab faces FDA decision ~May 2026. FDA rejected it once — not for science, but for a factory inspection. EU approved it in Jan 2025. US is next. Here's why this myeloma drug comeback story matters 🧵👇

@WSJ 72% odds of FDA approval for $SNY's new oral drug for progressive MS 🤞x.com/AlertsFda/stat…

The drugmaker said the results provide convincing evidence that fenebrutinib can become the first high-efficacy oral treatment for relapsing and primary progressive multiple sclerosis. on.wsj.com/4cmViIC

@semodough 72% odds of FDA approval for $SNY's new oral drug for progressive MS 🤞x.com/AlertsFda/stat…

$SNY FDA has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients. sanofi.com/en/media-room/…

@teachplaygrub 72% odds of FDA approval for $SNY's new oral drug for progressive MS 🤞x.com/AlertsFda/stat…

Have MULTIPLE questions about MULTIPLE sclerosis?   Having trouble seeing neuromyelitis optica?   In a fog about MOG?   Here’s the cheat sheet you NEED to distinguish the demyelinating diseases!   Demyelinating diseases predominantly involve the optic nerves, brain, & spine.    The three main chronic demyelinating diseases are Multiple sclerosis (most common), neuromyelitis optica (NMO), & myelin oligodendrocyte glycoprotein (MOG) antibody associated disease or MOGAD   Each has its own features in the optic nerve, brain, & spine.  Here’s how to remember them!   MS Optic nerve: MS only has 2 letters, so MS involvement of the optic nerve tends to be short segment Brain: Letter M makes the shape of the perivascular distribution of lesions along the ventricles (Dawson’s fingers) Letter S makes the shape of the subcortical U fiber involvement Spine: MS is only 2 letters, so lesions are usually less than 2 vertebral bodies in length   NMO Optic nerve: NMO is a longer abbreviation, three letters, so longer involvement NMO can stand for Near My Occiput. Occiput is posterior, so more posterior nerve involvement Brain: NMO can stand for Near My Ocean. What is your brain’s ocean? The ventricles. NMO lesions are all periventricular Spine: NMO is 3 letters, so lesions usually more than 3 vertebral bodies in length   MOGAD Optic Nerve: Remember MO’ GAD-olinium.  So things that cause more regions of enhancement.  MOGAD lesions are commonly bilateral & long segment & enhancement can extend perineural Brain: Remember LO’ GAD.  MOGAD typically involves the lower areas of the brain Spine: Remember MO’ PLAID. MOGAD can give a plaid-like H shape in the cord from predominantly gray matter involvement   Hopefully, this cheat sheet will help you remember how to distinguish the demyelinating diseases! It ain’t lyin’ about diseases of myelin!

@CellCellPress 72% odds of FDA approval for $SNY's new oral drug for progressive MS 🤞x.com/AlertsFda/stat…

In the latest issue! Anti-BCMA CAR-T therapy in patients with progressive multiple sclerosis dlvr.it/TPK7rc