Biotech desk
Biotech catalysts
FDA decisions, trial results and share sales for US biotech stocks.
Each line is a headline from our live news feed. You see when it came out, to the second. You also see how the stock moved 1 minute and 10 minutes later.
FDA decisions
Approvals, rejection letters and advisory votes. Also clinical holds and accepted filings.
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FDA accepts Biohaven’s resubmitted Vyglxia application for spinocerebellar ataxia
1 min+0.35%10 min+9.33%
1 more headline on this
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FDA approves Edwards Lifesciences’ PASCAL Precision for tricuspid valve repair and clears PASCAL Ace with Capture Clarity for degenerative mitral valve repair
1 min−0.02%10 min−0.01%
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FDA sets March 25, 2027, target action date for Unicycive Therapeutics' OLC NDA
1 min0.00%10 min−1.54%
1 more headline on this
- Unicycive Therapeutics says FDA accepted its resubmitted NDA for oxylanthanum carbonate1 min+0.13%10 min+0.13%
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FDA approves Biocryst’s Orladeyo 150 mg oral pellets for adults and adolescents with HAE
No measured move
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GSK says the US FDA approved Hibsago for chronic hepatitis B
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FDA approves Zoetis’ Convenia RTU cefovecin injectable suspension for dogs, expanding single-injection treatment access to medium and large dogs
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Penumbra receives FDA clearance for Lightning thrombectomy technology to treat deep vein thrombosis; BOLT-DVT trial reports complete or near-complete clot removal in 98% of patients
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FDA approves Alvotech's Simlandi
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FDA approves Haemonetics’ Perqseal® Elite vascular closure system
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FDA clears combined use of Solventum’s Restrata Synthetic Electrospun Fiber Matrix and Solventum V wound care technologies
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AnaptysBio says FDA clears GSK’s Jemperli as the first immunotherapy for adults with stage II-III MSI-H/dMMR locally advanced rectal cancer
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- AnaptysBio-discovered drug receives FDA approval to treat rectal cancer1 min−0.10%10 min−0.05%
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CorMedix says FDA accepted its supplemental application for priority review of Rezzayo for invasive fungal disease prevention
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Atara announced that the FDA has accepted its resubmitted BLA for Tab-cel, with a PDUFA date set for March 31, 2027.
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BridgeBio's infigratinib NDA for treating achondroplasia receives FDA acceptance and priority review, with a PDUFA date of February 4, 2027.
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BridgeBio announced that the FDA has accepted its NDA for encaleret for autosomal dominant hypocalcemia type 1, with a PDUFA date of May 8, 2027.
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Teva announced FDA approval for Weltruza, a monthly injection for schizophrenia treatment.
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FDA approves Pfizer's Tukysa for front-line maintenance treatment of certain breast cancer patients.
1 min0.00%10 min+0.07%
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FDA grants approval to Novartis AG's Rhapido (Remibrutinib) as the inaugural treatment for symptomatic dermographism.
No measured move
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BridgeBio's NDA for oral infigratinib for children with achondroplasia receives FDA acceptance and priority review.
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Abbott has gained FDA approval for enhanced capabilities of its CardioMEMS HF system to assist patients in managing their heart conditions.
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Establishment Labs has gained FDA approval for new sizes of its Motiva implants.
1 min0.00%10 min+0.84%
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FDA approves Alvotech's second Reykjavik facility for SIMLANDI drug substance production, doubling U.S. capacity.
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Lilly announces FDA approval for expanded first-line use of Jaypirca in treating adults with CLL/SLL without known 17p deletion.
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Edwards Lifesciences receives FDA approval for its AUTUS pediatric pulmonary valve, designed to minimize repeat surgeries.
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Bristol Myers Squibb's Camzyos receives FDA approval for expanded use in treating symptomatic OHCM in adults and children.
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AbbVie's Parkinson's disease drug receives FDA approval for adults.
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US FDA grants approval for Mirum Pharmaceuticals' treatment of a rare bone disorder.
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MERCK SHARES FLAT IN VOLUME SPIKE AFTER FDA APPROVES KIDNEY DRUG, LAST UP 0.50% AT $148.81
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Mesoblast wins FDA approval for new potency assay for Ryoncil commercial lots
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US FDA approves Lilly's once-weekly insulin injection for type 2 diabetes
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FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri(R) Multi-Cancer Early Detection Test
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Trisalus Life Sciences Receives FDA Clearance For Trinav Advance
1 min+6.49%10 min+32.86%
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FILANA THERAPEUTICS ANNOUNCES FDA LIFT OF CLINICAL HOLD ON SIMUFILAM, ENABLING PHASE 2A STUDY IN TSC-RELATED EPILEPSY
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FDA grants priority review to Insmed ARIKAYCE MAC lung disease sNDA, PDUFA set for Jan. 28, 2027
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Amneal Gets FDA Approval for Generic Hormone Drug
1 min+0.21%10 min+2.68%
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US FDA approves Lilly's breast cancer drug combo
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Ultragenyx Pharmaceutical Rises After FDA Approves Fayuvi for Sanfilippo Syndrome Type A
1 min+0.15%10 min+1.90%
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Medtronic wins FDA clearance for LigaSure RAS Maryland device for Hugo robot system
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COGENT BIOSCIENCES ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION (NDA) FOR BEZUCLASTINIB IN PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM)
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FDA approves shorter monitoring time for Amgen’s Imdelltra first two doses
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Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA(R), a Hormone-Free Intrauterine Device
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- Organon says FDA accepts Miudella IUD sNDA for 6-year use reviewNo measured move
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BETA BIONICS ANNOUNCES FDA CLEARANCE OF MINT™, THE COMPANY’S TRANSFORMATIVE PATCH PUMP, AND UNVEILS 3D INTELLIGENCE™ AS ITS NEXT-GENERATION INSULIN DOSING ALGORITHM
1 min+1.50%10 min+2.04%
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U.S. FDA Accepts New Drug Application Under Priority Review for Takeda's Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment Expectations
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TELIX PHARMACEUTICALS LIMITED-FDA APPROVES TELIX BRAIN CANCER IMAGING DRUG PIXCLARA
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- FDA approves Telix brain cancer imaging drug Pixclara for glioma PET scansNo measured move
- FDA Approves Telix's Brain Cancer Imaging Drug PixclaraNo measured move
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US FDA approves Scholar Rock's muscle weakness drug
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Outlook Therapeutics wins FDA approval for LYTENAVA in wet AMD
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Humacyte announced FDA approval for extending the shelf life of Symvess to 36 months from 18 months under refrigerated conditions.
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Abbott Secures FDA Approval for TactiFlex Duo Ablation Catheter to Address Abnormal Heart Rhythms
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Intellia Therapeutics reports FDA has accepted its biologics license application for Lonvoguran Ziclumeran (Lonvo-Z) with priority review for hereditary angioedema.
1 min+1.26%10 min+5.96%
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Belite Bio's NDA for Tinlarebant receives FDA priority review, with a PDUFA date set for February 12, 2027.
No measured move
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Guardant Health receives FDA approval for Guardant360® CDX as a companion diagnostic for AstraZeneca’s Etcamah™ (Camizestrant) in advanced breast cancer.
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FDA grants accelerated approval to AstraZeneca's Etcamah for advanced breast cancer treatment.
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U.S. FDA grants approval for Ionis Pharmaceuticals' therapy targeting a rare brain disorder.
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Modular Medical receives FDA approval for software upgrades to Pivot insulin patch pump.
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United Therapeutics Corporation reports FDA acceptance of supplemental new drug application for nebulized Tyvaso® aimed at treating idiopathic pulmonary fibrosis.
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The FDA has approved the first treatment specifically targeting dermatomyositis developed by Roivant.
1 min0.00%15 min+0.26%
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FDA Clears Gilead's New Single Tablet HIV Regimen
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Takeda has received FDA approval for its innovative blood cancer medication.
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Jazz Pharmaceuticals announces FDA approval for Ziihera combinations in first-line treatment of HER2+ advanced gastroesophageal cancer.
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Alvotech's biologics license application for AVT80 has been accepted for FDA review, aiming to expand its biosimilar program for Entyvio® to subcutaneous forms.
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Takeda receives FDA approval for MIMRYLO (rusfertide) to treat adults with polycythemia vera.
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The FDA has approved Mounjaro (tirzepatide) from Lilly (LLY) for the purpose of decreasing cardiovascular risk in adults suffering from type 2 diabetes.
No measured move
2 more headlines on this
- Eli Lilly Says FDA Approves Mounjaro, a Dual GIP and GLP-1 Hormone Receptor Agonist, to Lower Risk of Major Adverse Cardiovascular Events in Adults with Type 2 DiabetesNo measured move
- Eli Lilly receives FDA approval for Mounjaro to lower cardiovascular risk in adults with type 2 diabetes.No measured move
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Gilead Sciences' Bixlenvo receives FDA approval for specific adults with HIV.
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Pfizer and BioNTech obtain U.S. FDA approval for their XFG-adapted COVID-19 vaccine.
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- FDA grants approval for new seasonal Covid-19 vaccines from Moderna, Pfizer, and BioNTech for 2026-2027.No measured move
- FDA Approves Updated COVID Vaccines from Moderna, Pfizer, NovavaxNo measured move
- FDA grants approval for new seasonal Covid-19 vaccines from Moderna, Pfizer, BioNTech, and Novavax for 2026-2027.No measured move
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Moderna received FDA approval for the 2026-2027 formulations of Spikevax and MNexSpike.
1 min−0.32%15 min−1.39%
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US FDA grants approval for Roivant and Priovant's first oral treatment for a rare skin and muscle disease.
1 min+0.27%15 min−0.67%
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The U.S. FDA has granted approval for Revolution Medicines' targeted drug for metastatic pancreatic cancer.
No measured move
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- The U.S. FDA has granted approval for Revolution Medicines' Rasonque™ (Daraxonrasib), marking it as the first broad RAS-targeted treatment for metastatic pancreatic cancer.No measured move
- Revolution Medicines announces FDA approval for RASONQUE.No measured move
- Revolution Medicines Wins FDA Approval for First-of-Its-Kind Pancreatic Cancer Drug1 min−0.30%10 min–
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FDA Approves Abbott's First Wearable Device for Dual Ketone and Glucose Tracking
1 min−0.33%15 min−0.70%
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Jazz Pharmaceuticals' Two Ziihera Regimens Receive FDA Approval to Treat Adults With Unresectable Locally Advanced or Metastatic Her2-Positive Gastroesophageal Adenocarcinoma
1 min+0.04%15 min+0.39%
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- Jazz Pharmaceuticals Receives FDA Approval for Two Advanced Gastric Cancer Regimens1 min−0.09%15 min−0.32%
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Johnson & Johnson Secures FDA Approval for First Rare Anemia Treatment
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Capricor Therapeutics Says FDA Extends PDUFA Target Action Date for BLA for Deramiocel, Investigational Cell Therapy for Duchenne Muscular Dystrophy, from August 22 to November 22
1 min−7.08%15 min−25.09%
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FDA Places Clinical Hold On Regenxbio's RGX-121 Following Asymptomatic Spine MRI Findings In Five CAMPSIITE Study Participants With Mucopolysaccharidosis Type II
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United Therapeutics Announces FDA Acceptance of NDA for Ralinepag in Pulmonary Arterial Hypertension, PDUFA Target Action Date June 24, 2027
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Regeneron Secures FDA Approval for Bone Disorder Drug
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Hyperfine Receives FDA Clearance for Optive AI Software Update; Plans U.S. Rollout in September
1 min−2.09%10 min–
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Femasys Says FDA Approved Modular PMA Pathway for FemBloc Non-Surgical Permanent Birth Control
No measured move
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Lantheus Holdings Announces FDA Approval Of TAUKLARIFY, Radiodiagnostic Agent Indicated For PET Of Brain In Adults For Alzheimer’s Disease
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1 more headline on this
- FDA Approves Lantheus Imaging Drug for Alzheimer's Diagnostics1 min+0.01%15 min0.00%
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Bristol-Myers Squibb Receives FDA Approval For ZENBEXUS In Combination With Daratumumab And Hyaluronidase-fihj and Dexamethasone For Patients with Multiple Myeloma
No measured move
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Belite Bio Announces FDA Acceptance And Priority Review Of Tinlarebant NDA For Stargardt Disease Type 1, With PDUFA Date Of February 12, 2027
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QIAGEN Says FDA Clears QIAstat-Dx BCID GPF Plus AMR Panel For Bloodstream Infections
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Labcorp Announces FDA Approval Of PGDx elio Tissue Complete CDx As Companion Diagnostic To Identify Advanced Melanoma Patients With BRAF V600E/K Variants
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Two Rejections, Messy Process: Replimune Finally Secures FDA Approval for Skin Cancer Treatment
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Beyond COVID: Moderna Wins FDA Approval for Its Seasonal Flu Vaccine
1 min+0.24%15 min−0.18%
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Update: Merck (MRK) announces that the US FDA has accepted a sBLA for ENFLONSIA to expand its indication to include prevention of RSV lower respiratory tract disease in children under two years of age at increased risk for severe RSV disease
No measured move
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Takeda's ORZEYFUL Wins FDA Approval As First Orexin Therapy For Narcolepsy Type 1; U.S. Launch Planned Following DEA Scheduling
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AbbVie's Allergan Aesthetics Receives FDA Acceptance For Review For Its Supplemental Biologics License Application For BOTOX Cosmetic
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Replimune Group Shares More Than Double After FDA Advisory Committee Backs RP1 Approval
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J&J (JNJ) unveils that the US FDA has granted Priority Review for subcutaneous amivantamab and hyaluronidase for adults with recurrent or metastatic head and neck squamous cell carcinoma
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Freenome said the FDA approved its SimpleScreen CRC blood-based screening test, with Abbott set to commercialize it in the U.S.
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Outlook Therapeutics closed up 6% at $1 after the FDA approved Lytenava to treat neovascular age-related macular degeneration.
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FDA Approves Mannkind's At-Home Treatment Option for Heart Failure or Kidney Disease
1 min0.00%15 min+0.12%
PDUFA dates ahead
A PDUFA date is the day the FDA aims to decide on a drug. These dates come from headlines in our feed.
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Nov 22, 2026In 31 days
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Jan 28, 2027In 98 days
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Feb 4, 2027In 105 days
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Feb 12, 2027In 113 days
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Mar 22, 2027In 151 days
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Mar 25, 2027In 154 days
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Mar 31, 2027In 160 days
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May 1, 2027In 191 days
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May 8, 2027In 198 days
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Jun 14, 2027In 235 days
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Jun 24, 2027In 245 days
Trial results
The main goal is the trial's primary endpoint. We show if a headline says it was met or missed.
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AbbVie (ABBV) reports positive topline findings from the Phase 3 INTREPID study, which assessed lutikizumab’s safety and efficacy in adults and adolescents with moderate to severe hidradenitis suppurativa
No measured move
- 2 more biotech headlines on the Pro feedSee them
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Roivant and Priovant report positive Phase 3 CLARITY-1 and CLARITY-2 trial results for brepocitinib in non-infectious uveitis
1 min+5.39%10 min+5.48%
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AstraZeneca's (AZN) Tezspire delivers clinically meaningful, statistically significant gains across the co-primary endpoints: histologic remission and dysphagia frequency and severity.
No measured move
- 10 more biotech headlines on the Pro feedSee them
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Vanda Pharmaceuticals pauses its social anxiety drug program after the experimental treatment misses the main goal in a late-stage study
1 min−16.86%10 min−10.69%
- 1 more biotech headline on the Pro feedSee them
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BioNTech's BNT113 cancer immunotherapy did not achieve the first dual primary endpoint of progression-free survival in a phase 2/3 trial.
1 min−0.91%10 min−2.79%
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- 2 more biotech headlines on the Pro feedSee them
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Bristol Myers Squibb's Phase 3 ALOFT-IPF trial shows that admilparant at 60 mg met its primary endpoint in adults with idiopathic pulmonary fibrosis.
No measured move
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MediciNova announced that its Phase 2 trial of MN-001 for NAFLD in patients with type 2 diabetes did not meet its primary endpoints.
1 min−11.18%10 min−11.84%
- 10 more biotech headlines on the Pro feedSee them
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Johnson & Johnson (JNJ) has revealed that in the Phase 4 STAR study, TREMFYA successfully achieved both the primary and significant secondary endpoints, showing improvements in axial symptoms and a decrease in inflammation as assessed by MRI.
No measured move
- 26 more biotech headlines on the Pro feedSee them
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Amgen (AMGN) has reported that its phase 3 DeLLphi-305 study yielded positive results, successfully achieving its primary endpoint with the use of IMDELLTRA alongside AstraZeneca's (AZN LN) Imfinzi.
1 min−0.12%10 min−0.14%
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- 7 more biotech headlines on the Pro feedSee them
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AbbVie (ABBV) reported that the Phase 3 CERVINO trial of etentamig in triple-class exposed RRMM patients achieved both primary endpoints.
No measured move
- 9 more biotech headlines on the Pro feedSee them
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Moderna Announces That Its MRNA-1403 Norovirus Vaccine Candidate Did Not Meet Statistical Criteria For Early Success At Phase 3 Interim Analysis; Now Preparing To Enroll An Additional Cohort
1 min−0.20%15 min+2.20%
- 1 more biotech headline on the Pro feedSee them
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Pfizer (PFE) unveils positive topline results from a Phase 3 LITFULO study with patients with nonsegmental vitiligo
No measured move