AAPL325.89-1.85 (-0.56%) ▼|ABBV253.29-2.81 (-1.10%) ▼|ABT100.60+0.93 (+0.93%) ▲|ACN140.09-0.77 (-0.55%) ▼|ADBE218.36-8.80 (-3.87%) ▼|AMAT553.92-10.63 (-1.88%) ▼|AMD552.33+7.90 (+1.45%) ▲|AMGN366.05-0.19 (-0.05%) ▼|AMT166.06+2.67 (+1.63%) ▲|AMZN244.85-2.70 (-1.09%) ▼|AVGO396.81+10.31 (+2.67%) ▲|AXP348.74-2.05 (-0.58%) ▼|BA208.65+3.85 (+1.88%) ▲|BAC61.62+0.40 (+0.65%) ▲|BKNG177.86-1.54 (-0.86%) ▼|BLK1,056.63+18.39 (+1.77%) ▲|BMY60.76-0.17 (-0.28%) ▼|BNY160.39+1.50 (+0.94%) ▲|BRK-B489.39-0.26 (-0.05%) ▼|C132.25-0.59 (-0.44%) ▼|CAT889.31-0.66 (-0.07%) ▼|CL91.63+1.13 (+1.25%) ▲|CMCSA23.52-0.29 (-1.22%) ▼|COF201.36-4.86 (-2.36%) ▼|COP118.79+1.29 (+1.10%) ▲|COST927.31-1.91 (-0.21%) ▼|CRM163.00-7.06 (-4.15%) ▼|CSCO112.21+0.03 (+0.03%) ▲|CVS108.08-2.52 (-2.28%) ▼|CVX192.98+1.91 (+1.00%) ▲|DE607.33+20.45 (+3.48%) ▲|DHR179.14+0.13 (+0.07%) ▲|DIS95.87-0.27 (-0.28%) ▼|DUK127.95+2.04 (+1.62%) ▲|EMR139.63+0.37 (+0.27%) ▲|FDX321.02+5.83 (+1.85%) ▲|GD373.16+5.43 (+1.48%) ▲|GE341.19+0.49 (+0.14%) 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▲|BAC61.62+0.40 (+0.65%) ▲|BKNG177.86-1.54 (-0.86%) ▼|BLK1,056.63+18.39 (+1.77%) ▲|BMY60.76-0.17 (-0.28%) ▼|BNY160.39+1.50 (+0.94%) ▲|BRK-B489.39-0.26 (-0.05%) ▼|C132.25-0.59 (-0.44%) ▼|CAT889.31-0.66 (-0.07%) ▼|CL91.63+1.13 (+1.25%) ▲|CMCSA23.52-0.29 (-1.22%) ▼|COF201.36-4.86 (-2.36%) ▼|COP118.79+1.29 (+1.10%) ▲|COST927.31-1.91 (-0.21%) ▼|CRM163.00-7.06 (-4.15%) ▼|CSCO112.21+0.03 (+0.03%) ▲|CVS108.08-2.52 (-2.28%) ▼|CVX192.98+1.91 (+1.00%) ▲|DE607.33+20.45 (+3.48%) ▲|DHR179.14+0.13 (+0.07%) ▲|DIS95.87-0.27 (-0.28%) ▼|DUK127.95+2.04 (+1.62%) ▲|EMR139.63+0.37 (+0.27%) ▲|FDX321.02+5.83 (+1.85%) ▲|GD373.16+5.43 (+1.48%) ▲|GE341.19+0.49 (+0.14%) ▲|GEV985.03-93.78 (-8.69%) ▼|GILD130.34+0.06 (+0.05%) ▲|GM82.13+2.61 (+3.28%) ▲|GOOG341.91-4.28 (-1.24%) ▼|GOOGL342.09-5.06 (-1.46%) ▼|GS1,098.20+12.64 (+1.16%) ▲|HD331.45-0.15 (-0.05%) ▼|HON232.99+3.13 (+1.36%) ▲|IBM205.77-4.73 (-2.25%) ▼|INTC102.62-2.83 (-2.68%) ▼|INTU284.47-5.45 (-1.88%) ▼|ISRG340.69-9.37 (-2.68%) ▼|JNJ255.63+5.02 (+2.00%) 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▲|TSLA374.01-4.92 (-1.30%) ▼|TXN294.19+2.89 (+0.99%) ▲|UBER70.33-1.22 (-1.71%) ▼|UNH431.31-5.04 (-1.16%) ▼|UNP292.56-0.57 (-0.19%) ▼|UPS115.84-0.50 (-0.43%) ▼|USB64.47+0.76 (+1.19%) ▲|V353.42-2.40 (-0.67%) ▼|VZ44.29+0.51 (+1.16%) ▲|WFC86.42-1.32 (-1.50%) ▼|WMT109.33-1.06 (-0.96%) ▼|XOM154.45+2.74 (+1.81%) ▲|
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Wednesday, July 22, 2026

Tag: license application

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...

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...

Singapore MAS Conducts Regulatory Review of SKHTU Exchange Compliance Application

DENVER, June 24, 2026 (GLOBE NEWSWIRE) -- Recently, SKHTU Exchange formally submitted its license application materials to the Monetary Authority of Singapore (MAS), marking the entry of the platforms compliance deployment in the Asian market into a substantive review phase. It is understood that the relevant application materials have completed preliminary acceptance, and the subsequent process will proceed to the document review and operational assessment stage in accordance with the regulatory procedures.

SKHTU Exchange Actively Engages With Regulatory Authorities To Advance FCA License Approval

DENVER, June 23, 2026 (GLOBE NEWSWIRE) -- Recently, regulatory oversight of digital assets in Europe has continued to intensify. SKHTU Exchange has formally submitted its license application materials to the UK Financial Conduct Authority (FCA) and maintains close communication with the regulatory body during the approval process.

Oklo, Centrus Sign Letter of Intent to Purchase Nuclear Fuel for Aurora Powerhouse Deployment in Southern Ohio

One of the first large-scale commercial high-assay low-enriched uranium (HALEU) supply agreements that could include prepayments from Oklo.Centrus to provide Oklo with enough HALEU...

uniQure Announces Plan for BLA Submission for AMT-130 in Huntington’s Disease

~ 3-year analysis from the Phase I/II study can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ~

New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma

TALVEY® plus DARZALEX FASPRO® with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 monthsMonumenTAL-3 is the...

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven...

Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as...

Humacyte, Inc. Announces Pricing of Public Offering of Common Stock

DURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the pricing of an underwritten public offering of 47,619,048 shares of its common stock at a public offering price of $1.05 per share. The aggregate gross proceeds from this offering are expected to be $50 million, before deducting underwriting discounts and commissions and other offering expenses payable by Humacyte. The closing of the offering is expected to occur on or about June 12, 2026, subject to the satisfaction of customary closing conditions. In addition, Humacyte has granted the underwriters an option for a period of 30 days to purchase up to an additional 7,142,857 shares of Humacyte’s common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being sold by Humacyte.

Futurionex Completes Client Asset Protection Upgrades, Plans MiCA License Submission in Q3 2026

DENVER, June 09, 2026 (GLOBE NEWSWIRE) -- Futurionex, a digital asset trading platform, today announced the completion of key enhancements to its client asset protection system. These improvements are part of the company’s preparations for its Markets in Crypto-Assets (MiCA) license application, which remains on track for submission in the third quarter of 2026.

Rakuten Medical Announces Executive Leadership Transition to Enhance Operational Execution and Organizational Discipline as a Global, Scalable Biotech Company

Minami Maeda appointed as CEO to drive faster, more focused execution toward U.S. commercial launchMickey Mikitani will continue to provide strategic direction and remains...

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

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