AAPL328.21+3.25 (+1.00%) ▲|ABBV260.21-1.51 (-0.58%) ▼|ABT108.79-1.68 (-1.52%) ▼|ACN193.12+5.44 (+2.90%) ▲|ADBE285.75+5.96 (+2.13%) ▲|AMAT435.91-2.55 (-0.58%) ▼|AMD456.16-0.90 (-0.20%) ▼|AMGN444.12+1.28 (+0.29%) ▲|AMT177.75+4.83 (+2.79%) ▲|AMZN258.90+3.92 (+1.54%) ▲|AVGO357.16-10.08 (-2.74%) ▼|AXP329.82-0.16 (-0.05%) ▼|BA210.51+1.64 (+0.79%) ▲|BAC63.04+0.44 (+0.70%) ▲|BKNG195.13-4.47 (-2.24%) ▼|BLK1,126.15+19.07 (+1.72%) ▲|BMY68.09+0.43 (+0.64%) ▲|BNY164.33+2.29 (+1.41%) ▲|BRK-B508.13+2.89 (+0.57%) ▲|C138.14+3.80 (+2.83%) ▲|CAT800.14+7.86 (+0.99%) ▲|CL90.09-0.01 (-0.01%) ▼|CMCSA26.65-0.16 (-0.60%) ▼|COF220.50+3.90 (+1.80%) ▲|COP135.72-1.48 (-1.08%) ▼|COST925.41-3.07 (-0.33%) ▼|CRM264.43+7.50 (+2.92%) ▲|CSCO108.61-0.85 (-0.77%) ▼|CVS97.20-0.03 (-0.03%) ▼|CVX211.32-0.46 (-0.22%) ▼|DE694.41-3.96 (-0.57%) ▼|DHR211.03+1.12 (+0.53%) ▲|DIS107.16-0.82 (-0.76%) ▼|DUK121.40+0.84 (+0.70%) ▲|EMR150.21+1.23 (+0.83%) ▲|FDX324.31+7.77 (+2.45%) ▲|GD365.87+1.80 (+0.49%) ▲|GE333.48+3.98 (+1.21%) 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▲|BAC63.04+0.44 (+0.70%) ▲|BKNG195.13-4.47 (-2.24%) ▼|BLK1,126.15+19.07 (+1.72%) ▲|BMY68.09+0.43 (+0.64%) ▲|BNY164.33+2.29 (+1.41%) ▲|BRK-B508.13+2.89 (+0.57%) ▲|C138.14+3.80 (+2.83%) ▲|CAT800.14+7.86 (+0.99%) ▲|CL90.09-0.01 (-0.01%) ▼|CMCSA26.65-0.16 (-0.60%) ▼|COF220.50+3.90 (+1.80%) ▲|COP135.72-1.48 (-1.08%) ▼|COST925.41-3.07 (-0.33%) ▼|CRM264.43+7.50 (+2.92%) ▲|CSCO108.61-0.85 (-0.77%) ▼|CVS97.20-0.03 (-0.03%) ▼|CVX211.32-0.46 (-0.22%) ▼|DE694.41-3.96 (-0.57%) ▼|DHR211.03+1.12 (+0.53%) ▲|DIS107.16-0.82 (-0.76%) ▼|DUK121.40+0.84 (+0.70%) ▲|EMR150.21+1.23 (+0.83%) ▲|FDX324.31+7.77 (+2.45%) ▲|GD365.87+1.80 (+0.49%) ▲|GE333.48+3.98 (+1.21%) ▲|GEV941.84+19.90 (+2.16%) ▲|GILD151.22+1.61 (+1.08%) ▲|GM87.22+2.35 (+2.77%) ▲|GOOG339.08+5.30 (+1.59%) ▲|GOOGL342.48+5.36 (+1.59%) ▲|GS1,037.93+33.51 (+3.34%) ▲|HD318.07+1.89 (+0.60%) ▲|HON207.63+1.56 (+0.76%) ▲|IBM234.71+3.01 (+1.30%) ▲|INTC91.67+1.62 (+1.80%) ▲|INTU344.30+1.36 (+0.40%) ▲|ISRG369.83-2.05 (-0.55%) ▼|JNJ278.43+3.22 (+1.17%) 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▲|TSLA376.37+19.36 (+5.42%) ▲|TXN257.46+3.63 (+1.43%) ▲|UBER76.63+0.67 (+0.88%) ▲|UNH398.39-2.56 (-0.64%) ▼|UNP289.85+0.71 (+0.25%) ▲|UPS103.00-0.51 (-0.49%) ▼|USB63.57+0.04 (+0.06%) ▲|V375.47-3.24 (-0.86%) ▼|VZ50.66+0.08 (+0.15%) ▲|WFC89.54+0.35 (+0.39%) ▲|WMT108.64+0.22 (+0.20%) ▲|XOM160.24-2.00 (-1.23%) ▼|
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Friday, September 4, 2026

Tag: regulatory approval

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Cellectis Receives FDA RMAT Designation for lasme-cel, the First Allogeneic CAR-T Therapy in a Pivotal Trial for Patients with r/r B-ALL

NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

Longeveron Granted Small or Medium-sized Enterprise (SME) Status by the European Medicines Agency (EMA)

Longeveron (LGVN) granted Small or Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA).

Selagine Plasma to Advance Pooled Plasma Eye Drops for Moderate-to-Severe Dry Eye

Agreement with Selagine, Inc. supports the development of an investigational pooled plasma biologic platform intended to move beyond individualized compounded serum tearsCHICAGO, June 9,...

Actuate Therapeutics’ Elraglusib Selected for Evaluation in BEACON2 Trial for High-Risk Pediatric Neuroblastoma

- BEACON2 is a landmark European multi-arm, multi-stage Phase 1/2 platform trial conducted and sponsored by the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham 

- Elraglusib will be assessed in combination with dinutuximab beta plus chemotherapy in patients with relapsed and refractory neuroblastoma

- Complete response in neuroblastoma patient achieved in Phase 1 study of elraglusib in refractory pediatric cancers

DBV Technologies to Present New Positive Data from VITESSE Study and Preview Recently Initiated THRIVE Study at the EAACI Congress 2026

Châtillon, France, June 8, 2026

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.

Sapu Nano Expands International Development of Sapu003 and Appoints Global Clinical Trials (GCT) as Lead CRO for Phase 1b Program

SAN DIEGO, June 8, 2026 /PRNewswire/ -- Sapu Bioscience LLC announced the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for...

LENZ Therapeutics Announces Everest Medicines Acquired Rights to Develop and Commercialize VIZZ® (LNZ100) in Greater China

The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027 
The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027

AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS

VESALIUS-CV Subgroup Results Show Repatha® Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk DiabetesNew Real-World Data Highlight Treatment...

Unlocking the Americas: Air Canada and Abra Group Sign Memorandum to Expand Travel and Connectivity between Canada, Latin America and Beyond

RIO DE JANEIRO, June 07, 2026 (GLOBE NEWSWIRE) -- Air Canada and Abra Group today announced they have signed a Memorandum of Understanding to develop a broad, long-term strategic partnership. The agreement between Canada’s largest airline and the Latin American air transport company, whose carriers include the Avianca and GOL brands, would enable the partners to expand their global reach, providing customers and shippers greater connectivity across North, Central and South America and beyond. Any final agreement is subject to final documentation and regulatory approval.

Unlocking the Americas: Air Canada and Abra Group Sign Memorandum to Expand Travel and Connectivity between Canada, Latin America and Beyond

Establishes pathway to strategic partnership of Air Canada and Abra Group and a joint business agreement Customers will benefit from an improved travel experience,...

Lilly’s triple agonist, retatrutide, drove substantial improvements in weight, A1C, knee osteoarthritis pain, and obstructive sleep apnea, demonstrating its remarkable potential to treat obesity...

In TRIUMPH-1, participants on retatrutide 12 mg lost an average of 70.3 lbs (28.3%) over 80 weeks, with 65.3% achieving a BMI below 30,...

Vireo Growth Inc. Completes Acquisition of Bridgewell Agribusiness LLC and Plans to Acquire Dispensaries in Nevada and Maryland

Vireo Growth Inc. completes acquisition of Bridgewell Agribusiness LLC and plans to acquire dispensaries in Nevada and Maryland.

Allianz Partners to Acquire nib Travel Portfolio, Strengthening Australian Market Offering

BRISBANE, Australia, June 5, 2026 /PRNewswire/ -- Allianz Partners today announced it has signed an agreement to acquire a large portion of nib's Australian...

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