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FDA accepts resubmitted application for Outlook Therapeutics' wet AMD drug ONS-5010 with review due by July 2026

Market News
16 Jun 2026
Globe News Wire
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Bullish
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Outlook Therapeutics announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA™, a treatment for wet age-related macular degeneration (wet AMD). The FDA classified the review as Class 1, setting a Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026. If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, offering standardized manufacturing and labeling. Outlook Therapeutics is preparing for a commercial launch pending approval, marking a significant step forward for treatment options in retinal diseases.

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Japanese firms use NVIDIA Nemotron to build AI tailored for local industries and workforce needs.

Japanese firms use NVIDIA Nemotron to build AI tailored for local industries and workforce needs.

Leading Japanese companies, startups, and research institutions are developing specialized AI models using NVIDIA Nemotron open models to address Japan's unique language, industrial, and workforce challenges. These AI applications range from enterpri...

Market News
Bullish
3 hours ago
China's $1.39T local debt cleanup slows growth, risking global market impact

China's $1.39T local debt cleanup slows growth, risking global market impact

China's $1.39 trillion program to clean up hidden local government debt is succeeding in reducing off-book borrowing but is causing austerity-like effects. Local governments, key drivers of infrastructure spending and economic growth, are cutting bac...

Market News
Bearish
4 hours ago
Tech and industrial giants drive strong Q2 growth with major revenue and income gains.

Tech and industrial giants drive strong Q2 growth with major revenue and income gains.

In Q2 2026, top contributors to growth included Taiwan Semiconductor Manufacturing, Alphabet, United Rentals, Apple, and Visa. Alphabet’s Google Search and Cloud segments showed robust revenue growth of 19% and 63%, respectively, boosting operating i...

Market News
Bullish
4 hours ago
ARCpoint delays annual financial filings due to funding issues, expects to file by Sept 29, 2026.

ARCpoint delays annual financial filings due to funding issues, expects to file by Sept 29, 2026.

ARCpoint Inc. announced it will likely miss the July 29, 2026 deadline to file its annual financial statements and related reports due to a lack of funds to pay auditors. The company has applied for a Management Cease Trade Order (MCTO) and awaits ap...

Market News
Bearish
4 hours ago
BlackRock posts record $15.3T AUM with $192B inflows and strong Q2 margins, boosting buy rating.

BlackRock posts record $15.3T AUM with $192B inflows and strong Q2 margins, boosting buy rating.

BlackRock reported strong Q2 results with net inflows of $192 billion, pushing assets under management (AUM) to a record $15.3 trillion. The firm's ETF business showed strong momentum, supported by new product launches and inclusion in Trump accounts...

Company Fundamentals
Bullish
4 hours ago
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