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New drugs, and what they change for your patients.

12 FDA approvals on file · newest

SpecialtyAll 12Cardiology 2Dermatology 1Endocrinology 1Gastroenterology 1Hematology 1Infectious Disease 1Nephrology 1Neurology 1Oncology 2Rheumatology 1
Evidence Head-to-head Placebo-controlled Open-label randomized
12 drugsacross all specialties · newest first
  1. Juvmo tavapadonParkinson's disease · NeurologyAdults with Parkinson's disease have a once-daily oral dopamine agonist that can be used with or without levodopa. In Phase 3 trials it improved activities of daily living scores in early disease and, added to levodopa, increased "on" time without troublesome dyskinesia.First selective D1/D5 agonist Placebo-controlled50 sec
  2. Mimrylo rusfertidePolycythemia vera · HematologyAdults with polycythemia vera who still need frequent phlebotomies despite existing therapy have a weekly injection that reduced the need for phlebotomy in its pivotal trial.First hepcidin mimetic Placebo-controlled35 sec
  3. Lisraya brepocitinibDermatomyositis · RheumatologyAdults with dermatomyositis now have an FDA-approved oral therapy that improved disease activity scores over placebo at one year. It carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis.First oral treatment for dermatomyositis Placebo-controlled50 sec
  4. Rasonque daraxonrasibMetastatic pancreatic adenocarcinoma · OncologyAdults with previously treated metastatic pancreatic adenocarcinoma have an oral targeted option that extended median overall survival over standard chemotherapy in its pivotal trial.First in class Head-to-head30 sec
  5. Lipfendra enlicitideHypercholesterolemia · CardiologyAdults who need more LDL-C lowering now have a PCSK9 inhibitor taken as a daily pill. Whether it reduces cardiovascular events has not been shown yet.First oral PCSK9 inhibitor Placebo-controlled40 sec
  6. Trutakna atacicept-vymjPrimary IgA nephropathy · NephrologyAdults with primary IgA nephropathy at risk of progression have a new weekly self-injected option that lowered proteinuria in its pivotal trial. Its effect on long-term kidney function is not yet established.First dual BAFF and APRIL inhibitor Placebo-controlled40 sec
  7. Baxfendy baxdrostatHypertension · CardiologyAdults whose blood pressure is not adequately controlled on other medicines have an add-on option that works by inhibiting aldosterone production. The pivotal trial enrolled patients already on two or more drugs. Potassium and sodium need to be checked before and during treatment.First in class Placebo-controlled45 sec
  8. Idvynso doravirine and islatravirHIV-1 infection · Infectious DiseaseSuppressed patients who need to switch have a complete two-drug daily tablet that contains no integrase inhibitor and no tenofovir. It is a switch option only, and patients with hepatitis B coinfection need separate monitoring and consideration of anti-HBV therapy.Only non-INSTI, tenofovir-free two-drug regimen Head-to-head55 sec
  9. Foundayo orforglipronChronic weight management · EndocrinologyAdults who qualify for weight management therapy have a GLP-1 receptor agonist option taken as a daily tablet. It should not be combined with another GLP-1 receptor agonist. Placebo-controlled55 sec
  10. Lifyorli relacorilantPlatinum-resistant ovarian cancer · OncologyAdding relacorilant to nab-paclitaxel lengthened both progression-free and overall survival in previously treated platinum-resistant disease. Patients who need chronic or frequent glucocorticoids were excluded from the trial. Open-label randomized40 sec
  11. Icotyde icotrokinraModerate-to-severe plaque psoriasis · DermatologyPatients aged 12 and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy have a once-daily pill that blocks the IL-23 receptor. In the head-to-head Phase 3 studies, approximately 70% of patients reached clear or almost clear skin at Week 16.First oral peptide to block the IL-23 receptor Head-to-head60 sec
  12. Lynavoy linerixibatCholestatic pruritus in primary biliary cholangitis · GastroenterologyPatients with PBC-related itch have an approved treatment for the symptom for the first time. The average itch improvement over placebo was under one point on a 0-10 scale, and diarrhea was common.First approved for cholestatic itch in PBC Placebo-controlled40 sec
FDA approval · New moleculeFirst selective D1/D5 agonist50-second read

Juvmotavapadon

AbbVie · Selective dopamine D1/D5 receptor agonist · Neurology

Bottom line for your patients

Adults with Parkinson's disease have a once-daily oral dopamine agonist that can be used with or without levodopa. In Phase 3 trials it improved activities of daily living scores in early disease and, added to levodopa, increased "on" time without troublesome dyskinesia.

Drug brief
Drug IQ
Who it is for
Adults with Parkinson's disease.
What changes
AbbVie states that currently available dopamine agonists primarily target D2/D3 receptors and that their use may be limited by tolerability concerns, while Juvmo selectively targets D1/D5 receptors. The Phase 3 TEMPO trials compared Juvmo with placebo, not with another dopamine agonist.
The evidence
In TEMPO-1 at week 26, MDS-UPDRS Part II scores changed by -1.6 (5 mg) and -1.7 (15 mg) versus +0.9 with placebo (p <0.0001 for each dose). In TEMPO-3 at week 26, Juvmo plus oral levodopa increased daily "on" time without troublesome dyskinesia by 1.7 hours versus 0.6 hours with placebo plus oral levodopa (p <0.0001).Placebo-controlled randomized trialTEMPO-1, TEMPO-2 and TEMPO-3 · Phase 3Randomized against placebo: shows that it works, not how it compares with existing treatments.
Watch for
Safety information lists low blood pressure including orthostatic hypotension, unusual urges, hallucinations and dyskinesia. The most common adverse events (at least 5% of patients) were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety without levodopa, and nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension with levodopa.
How it is given
OralTablet taken once daily, with or without levodopa.
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.

On the horizon

Decisions the FDA has not made yet.

Applications under review, soonest first. Each date is the FDA's target as the company states it. Dates move, and a decision can go either way.

  1. FDA target
    Deramiocel
    Duchenne muscular dystrophy · Neurology · Capricor Therapeutics

    Capricor describes Deramiocel as an investigational cell therapy for Duchenne muscular dystrophy, and has asked the FDA to review a refined proposed indication focused on upper limb function.

    BLA under FDA reviewCapricor Therapeutics press release
  2. FDA target
    Saroglitazar
    Primary biliary cholangitis · Gastroenterology · Zydus Lifesciences

    Zydus describes saroglitazar as a PPAR alpha/gamma agonist, proposed with UDCA in adults with an inadequate response to it, or alone in patients who cannot tolerate UDCA.

    NDA under priority reviewZydus Lifesciences press release
  3. FDA target
    D-PLEX100 doxycycline (local prolonged release)
    Prevention of surgical site infection in abdominal colorectal surgery · Surgery · PolyPid

    PolyPid describes D-PLEX100 as a product placed in the surgical site that is designed to release the antibiotic doxycycline locally over a prolonged period to prevent abdominal surgical site infections.

    NDA under priority reviewPolyPid press release
  4. FDA target
    Ulixacaltamide ulixacaltamide HCl
    Essential tremor in adults · Neurology · Praxis Precision Medicines

    Praxis describes ulixacaltamide as a selective small molecule inhibitor of T-type calcium channels, studied in the Essential3 Phase 3 program for essential tremor in adults.

    NDA under FDA reviewPraxis Precision Medicines press release
  5. FDA target
    Reblozyl luspatercept
    Myelofibrosis-associated anemia · Hematology · Bristol Myers Squibb

    It would be a new indication for Reblozyl, used with concomitant janus kinase inhibitor therapy in adults with myelofibrosis-associated anemia who receive red blood cell transfusions.

    sBLA under FDA reviewBristol Myers Squibb Q2 2026 results release

How to read a brief

What the labels tell you, and what they do not.

“FDA approved” says a drug cleared the bar. These labels say how, and how directly the evidence answers the question you have in clinic.

The evidence marks

How directly the pivotal trial compares the drug with an existing option. They describe the trial design. They do not grade the drug.

Head-to-head randomized trial
Randomized against an active treatment: the most direct evidence on how it compares with an existing option.
Placebo-controlled randomized trial
Randomized against placebo: shows that it works, not how it compares with existing treatments.
Open-label randomized trial
Randomized, but patients and clinicians knew the assignment, so subjective outcomes are more open to bias.
Single-arm study
No randomized comparison group: the result is judged against historical expectations.

Review pathways

FDA designations describe the review, and sometimes the evidence standard. Shown on a brief only when the source states them.

Priority review
The FDA aimed to decide in about 6 months instead of the standard 10. A faster clock, not a higher or lower evidence bar.
Breakthrough therapy
Early clinical evidence suggested a substantial improvement over available therapy, so the FDA worked closely with the developer. Approval still required the full evidence.
Fast track
For a serious condition with unmet need: more FDA meetings and rolling review. A process designation, not a verdict on efficacy.
Orphan drug
Developed for a condition affecting fewer than 200,000 people in the US. Trials are often smaller.
Accelerated approval
Approved on a surrogate or intermediate endpoint reasonably likely to predict benefit. A confirmatory trial is required, and approval can be withdrawn if the benefit is not confirmed.

What changed

New does not always mean a new drug.

New molecule
An active ingredient the FDA had not approved before.
New indication
An already-approved drug, now approved for an additional use.
New formulation
A known drug in a new form, route or schedule.

Where every line comes from

Each brief is written from one primary source, the FDA's announcement or the developer's own release, with AI assistance. No figure or date is published that the source does not carry, and the source is one click away on every brief.

As of , Clintelo's drug search covers 12 FDA drug approvals from March 2026 to September 2026 across 10 specialties (cardiology, dermatology, endocrinology, gastroenterology, hematology, infectious disease, nephrology, neurology, oncology and rheumatology): Juvmo (tavapadon), Mimrylo (rusfertide), Lisraya (brepocitinib), Rasonque (daraxonrasib), Lipfendra (enlicitide), Trutakna (atacicept-vymj), Baxfendy (baxdrostat), Idvynso (doravirine/islatravir), Foundayo (orforglipron), Lifyorli (relacorilant), Icotyde (icotrokinra) and Lynavoy (linerixibat). It also tracks 5 applications awaiting an FDA decision.