AAPL343.46+1.46 (+0.43%) ▲|ABBV285.42+2.02 (+0.71%) ▲|ABT104.89+0.21 (+0.20%) ▲|ACN229.68+4.76 (+2.12%) ▲|ADBE245.20-6.47 (-2.57%) ▼|AMAT409.29-20.72 (-4.82%) ▼|AMD528.75-33.48 (-5.95%) ▼|AMGN432.49-1.54 (-0.35%) ▼|AMT185.27+3.91 (+2.16%) ▲|AMZN250.00-4.76 (-1.87%) ▼|AVGO328.75-15.58 (-4.52%) ▼|AXP313.59-0.28 (-0.09%) ▼|BA190.21+1.48 (+0.78%) ▲|BAC51.23-0.47 (-0.91%) ▼|BKNG163.45-2.35 (-1.42%) ▼|BLK1,134.38+13.60 (+1.21%) ▲|BMY59.75-0.82 (-1.35%) ▼|BNY143.30+1.21 (+0.85%) ▲|BRK-B532.02+6.34 (+1.21%) ▲|C124.26+1.05 (+0.85%) ▲|CAT730.76-4.88 (-0.66%) ▼|CL94.11+1.44 (+1.55%) ▲|CMCSA21.90+0.13 (+0.60%) ▲|COF201.74+2.88 (+1.45%) ▲|COP146.51+4.78 (+3.37%) ▲|COST989.11+11.10 (+1.14%) ▲|CRM240.70-6.04 (-2.45%) ▼|CSCO107.39-2.46 (-2.24%) ▼|CVS92.36-0.22 (-0.24%) ▼|CVX224.99+5.67 (+2.59%) ▲|DE641.86-8.81 (-1.35%) ▼|DHR229.04-2.46 (-1.06%) ▼|DIS110.59-0.09 (-0.08%) ▼|DUK121.47+2.59 (+2.18%) ▲|EMR161.47-0.68 (-0.42%) ▼|FDX293.55-1.99 (-0.67%) ▼|GD344.23+7.20 (+2.14%) ▲|GE313.83+1.83 (+0.59%) 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▲|TSLA354.72-7.72 (-2.13%) ▼|TXN276.48-2.64 (-0.95%) ▼|UBER70.35-0.92 (-1.29%) ▼|UNH401.43-5.24 (-1.29%) ▼|UNP289.04+0.33 (+0.11%) ▲|UPS97.48-0.35 (-0.36%) ▼|USB58.73+1.34 (+2.33%) ▲|V402.61+2.86 (+0.72%) ▲|VZ44.79+0.39 (+0.88%) ▲|WFC83.87+1.12 (+1.35%) ▲|WMT118.81+0.94 (+0.80%) ▲|XOM178.98+4.30 (+2.46%) ▲|
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Sunday, October 18, 2026

Tag: FDA

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.

Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy

The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society...

Beyond Injections: S-CELL Unveils Breakthrough “Endogenous GLP-1” Formula Powered by Akkermansia P9 Signaling and CoreBiome® Technology

HONG KONG, June 26, 2026 /PRNewswire/ -- S-CELL, a premier innovator in cellular health and anti-aging biotechnology, today announced the launch of its advanced...

Everest Medicines Announces China NMPA Acceptance of the Biologics License Application for LEROCHOL® in Adults with Hypercholesterolemia

SHANGHAI, June 26, 2026 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing...

Bee Naturals Releases Report on Rising Niacinamide Concentrations in Skincare Products

FDA-registered manufacturer examines growing use of high-concentration niacinamide formulas and reports that ingredient balance may play a greater role in product performance than active percentage alone.
FDA-registered manufacturer examines growing use of high-concentration niacinamide formulas and reports that ingredient balance may play a greater role in product performance than active percentage alone.

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