AAPL333.74+0.48 (+0.14%) ▲|ABBV254.49+0.10 (+0.04%) ▲|ABT100.68+1.85 (+1.87%) ▲|ACN143.57-1.04 (-0.72%) ▼|ADBE237.25+1.94 (+0.82%) ▲|AMAT529.66-31.27 (-5.57%) ▼|AMD495.76-5.18 (-1.03%) ▼|AMGN366.29-5.29 (-1.42%) ▼|AMT170.06+1.14 (+0.67%) ▲|AMZN247.23-2.66 (-1.06%) ▼|AVGO370.83-3.63 (-0.97%) ▼|AXP355.35-6.22 (-1.72%) ▼|BA214.03-0.31 (-0.14%) ▼|BAC61.27-0.22 (-0.36%) ▼|BKNG181.68-2.93 (-1.59%) ▼|BLK1,072.20-14.85 (-1.37%) ▼|BMY60.74+0.23 (+0.38%) ▲|BNY157.13-3.73 (-2.32%) ▼|BRK-B490.91-2.21 (-0.45%) ▼|C129.36-2.35 (-1.78%) ▼|CAT880.28+3.11 (+0.35%) ▲|CL92.98-1.09 (-1.16%) ▼|CMCSA23.79-0.31 (-1.29%) ▼|COF208.03-3.90 (-1.84%) ▼|COP114.71+1.87 (+1.66%) ▲|COST940.87-4.70 (-0.50%) ▼|CRM170.77-1.91 (-1.11%) ▼|CSCO111.94+2.28 (+2.08%) ▲|CVS107.47+0.97 (+0.91%) ▲|CVX187.38+3.52 (+1.91%) ▲|DE597.24-1.73 (-0.29%) ▼|DHR203.83-1.18 (-0.58%) ▼|DIS97.67-2.04 (-2.05%) ▼|DUK125.01-1.10 (-0.87%) ▼|EMR139.54+0.46 (+0.33%) ▲|FDX312.98-5.22 (-1.64%) ▼|GD368.58-0.24 (-0.07%) ▼|GE348.83+3.10 (+0.90%) 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▼|BAC61.27-0.22 (-0.36%) ▼|BKNG181.68-2.93 (-1.59%) ▼|BLK1,072.20-14.85 (-1.37%) ▼|BMY60.74+0.23 (+0.38%) ▲|BNY157.13-3.73 (-2.32%) ▼|BRK-B490.91-2.21 (-0.45%) ▼|C129.36-2.35 (-1.78%) ▼|CAT880.28+3.11 (+0.35%) ▲|CL92.98-1.09 (-1.16%) ▼|CMCSA23.79-0.31 (-1.29%) ▼|COF208.03-3.90 (-1.84%) ▼|COP114.71+1.87 (+1.66%) ▲|COST940.87-4.70 (-0.50%) ▼|CRM170.77-1.91 (-1.11%) ▼|CSCO111.94+2.28 (+2.08%) ▲|CVS107.47+0.97 (+0.91%) ▲|CVX187.38+3.52 (+1.91%) ▲|DE597.24-1.73 (-0.29%) ▼|DHR203.83-1.18 (-0.58%) ▼|DIS97.67-2.04 (-2.05%) ▼|DUK125.01-1.10 (-0.87%) ▼|EMR139.54+0.46 (+0.33%) ▲|FDX312.98-5.22 (-1.64%) ▼|GD368.58-0.24 (-0.07%) ▼|GE348.83+3.10 (+0.90%) ▲|GEV1,057.84+21.62 (+2.09%) ▲|GILD134.28-2.02 (-1.48%) ▼|GM76.07-1.65 (-2.12%) ▼|GOOG346.12-7.69 (-2.17%) ▼|GOOGL346.77-7.69 (-2.17%) ▼|GS1,065.22-30.24 (-2.76%) ▼|HD338.87-9.15 (-2.63%) ▼|HON225.02-1.31 (-0.58%) ▼|IBM212.67-6.38 (-2.91%) ▼|INTC95.04-1.94 (-2.00%) ▼|INTU291.09-3.70 (-1.26%) ▼|ISRG345.42-56.91 (-14.15%) ▼|JNJ253.04+3.07 (+1.23%) ▲|JPM341.10-2.05 (-0.60%) ▼|KO81.56-3.36 (-3.96%) ▼|LIN513.22-7.52 (-1.44%) ▼|LLY1,179.11+9.94 (+0.85%) ▲|LMT508.77-4.75 (-0.93%) ▼|LOW208.73-7.43 (-3.44%) ▼|LRCX313.30-7.66 (-2.39%) ▼|MA543.60-7.94 (-1.44%) ▼|MCD267.71-5.75 (-2.10%) ▼|MDLZ61.00-0.42 (-0.68%) ▼|MDT83.20-0.36 (-0.43%) ▼|META646.01-18.53 (-2.79%) ▼|MMM159.84-1.93 (-1.19%) ▼|MO74.21+1.18 (+1.62%) ▲|MRK127.50-0.13 (-0.10%) ▼|MS215.50-2.87 (-1.31%) ▼|MSFT393.82-7.28 (-1.82%) ▼|MU848.95-4.25 (-0.50%) ▼|NEE88.80-0.55 (-0.62%) ▼|NFLX68.95-5.40 (-7.26%) ▼|NKE43.76-0.81 (-1.82%) ▼|NOW103.24-0.77 (-0.74%) ▼|NVDA202.81-4.59 (-2.21%) ▼|ORCL126.41+2.20 (+1.77%) ▲|PEP137.12-2.31 (-1.66%) ▼|PFE25.05-0.09 (-0.36%) ▼|PG149.98-1.52 (-1.00%) ▼|PLTR132.38-2.06 (-1.53%) ▼|PM192.98+3.14 (+1.65%) ▲|QCOM171.78+1.11 (+0.65%) ▲|RTX193.51-0.85 (-0.44%) ▼|SBUX105.49-2.88 (-2.66%) ▼|SCHW101.56-1.24 (-1.21%) ▼|SO95.30-0.77 (-0.80%) ▼|SPG228.70+0.21 (+0.09%) ▲|T21.81-0.17 (-0.77%) ▼|TMO532.48-10.71 (-1.97%) ▼|TMUS192.43-0.42 (-0.22%) ▼|TSLA380.84-10.22 (-2.61%) ▼|TXN284.02-7.20 (-2.47%) ▼|UBER72.46-1.58 (-2.13%) ▼|UNH426.09+2.71 (+0.64%) ▲|UNP301.75+2.33 (+0.78%) ▲|UPS117.72+0.54 (+0.46%) ▲|USB63.14-0.87 (-1.36%) ▼|V358.56-6.58 (-1.80%) ▼|VZ43.59-0.29 (-0.66%) ▼|WFC87.51-0.56 (-0.64%) ▼|WMT114.24-0.71 (-0.62%) ▼|XOM147.36+1.41 (+0.97%) ▲|
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Sunday, July 19, 2026

Tag: FDA

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Appili Therapeutics Reports Fiscal Year 2026 Financial and Operational Results

LIKMEZ® (ATI-1501) commercial momentum building in U.S. market

US$40 million NIAID award supporting VXV-01 advancement through Phase 1

SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease

SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis Approval includes a...

Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of...

WILMETTE, Ill., June 26, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate choline, TMC) will be presented at the 12th Congress of the European Academy of Neurology (EAN 2026), June 27–30, 2026, in Geneva, Switzerland. These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus standard of care.

Larimar Therapeutics Announces Investor Event on the Nomlabofusp Program for Friedreich’s Ataxia

BALA CYNWYD, Pa., June 26, 2026 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host an investor event to discuss updates for the Company’s nomlabofusp clinical development program including a regulatory update and data from the ongoing long-term open label study for the treatment of Friedreich’s ataxia on Monday, June 29, 2026 at 7:45 am ET.

Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)

BEDFORD, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs). 

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

STOCKHOLM, June 26, 2026 /PRNewswire/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical...

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

STOCKHOLM, June 26, 2026 /PRNewswire/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical...

Siren Biotechnology Awarded $8M in Non-Dilutive Grant Funding from the California Institute for Regenerative Medicine (CIRM) to Support Clinical Development of SRN-101 in High-Grade...

Siren Biotechnology awarded $8M in grant funding from the California Institute for Regenerative Medicine (CIRM) to support clinical development of SRN-101

Johnson & Johnson presents new IMAAVY®▼ (nipocalimab) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalised myasthenia gravis

BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY®▼(nipocalimab) throughout clinically relevant points in the generalised myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChRa or anti-MuSKb antibody-positive gMG who were early in their disease course or had lower baseline symptom burden – providing insight into the potential importance of addressing pathogenic immunoglobulin G (IgG) early in disease progression where use of advanced therapies may be less common.1,2 Additional research to be shared include outcomes shortly after common infections, which are a known cause of disease exacerbations in gMG, and plans to address evidence gaps in the use of nipocalimab during pregnancy.3,4

Johnson & Johnson presents new IMAAVY® (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis

New analyses from the Phase 3 Vivacity-MG3 study support the impact of IMAAVY in anti-AChR+a, anti-MuSK+b adult patients with generalized myasthenia gravis (gMG) including...

FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health

If finalized, rule would level the playing field between American and foreign businesses 
If finalized, rule would level the playing field between American and foreign businesses

Lupin Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets

MUMBAI, India and NAPLES, Fla., June 26, 2026 /CNW/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)...

Anixa Biosciences Reports Positive Data from Completed Breast Cancer Vaccine Phase 1 Trial and Positive Survival Observations from Ongoing CAR-T Phase 1 Trial at...

Breast cancer vaccine presentation includes final Phase 1 data showing all major primary endpoints were met and protocol-defined immune responses in 74% of participantsOvarian...

Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual Conference

SAN DIEGO, June 26, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive five-year data from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company’s lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). The data will be presented at the Parent Project Muscular Dystrophy (PPMD) 2026 Annual Conference, taking place June 25-27, 2026, in Orlando, Florida, alongside previously reported results from the Company’s HOPE-3 Phase 3 trial.

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