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FDA News News 10 August 2025 - 13 November 2025

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (NASDAQ: OTLK) shares jumped today after the U.S. FDA accepted the company’s resubmitted Biologics License Application (BLA) for ONS‑5010/LYTENAVA, its bevacizumab-based eye drug for wet AMD, and set a PDUFA review date of December 31, 2025. Here’s what investors need to know. What Outlook Therapeutics announced today This morning, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the company’s resubmitted Biologics License Application for ONS‑5010 (bevacizumab‑vikg)/LYTENAVA, its investigational ophthalmic formulation of bevacizumab for the treatment of wet age‑related macular degeneration (wet AMD). GlobeNewswire+2Outlook Therapeutics+2 According to the company’s press release and
13 November 2025
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J&J Makes Bold Move: Orthopedics Spin-Off (“DePuy Synthes”) Announced – 2025 Forecast Raised

NJ Stock: What to Know Before the Bell on November 10, 2025 (Fresh FDA Wins, Dividend Date, and Legal Overhang)

Dateline: Monday, November 10, 2025 — pre‑market Johnson & Johnson (NYSE: JNJ) starts the new week with momentum from multiple drug approvals, a firm dividend timetable, and a still‑active litigation backdrop. Here’s a concise, investor‑focused briefing on the key developments likely to guide JNJ sentiment before the U.S. market opens today. Key takeaways• Q3 beat and higher 2025 sales outlook; adjusted EPS guidance reaffirmed. JNJ.com+1• Two fresh FDA wins in the past few weeks: Caplyta add‑on use in depression and Darzalex Faspro for high‑risk smoldering myeloma. Reuters+1• Inlexzo bladder‑cancer device approval broadens 2025 product catalysts. U.S. Food and Drug Administration•
9 November 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Sarepta (SRPT) Stock Collapses 80% on FDA Bombshell – Is a Big Rebound Coming?

SRPT Stock Price & Recent Performance Sarepta’s stock has experienced a dramatic collapse in 2025, wiping out years of gains. After starting the year near all-time highs, SRPT shares have plunged by over 80% year-to-date marketbeat.com. As of early November 2025, the stock trades in the mid-teens, down from about $120–$130 at the start of the year. In fact, the stock’s 52-week range tells the story: it hit a high of $138.81 and a low of just $10.41 over the past year marketbeat.com. This implosion has vastly underperformed the biotech sector (for context, the biotech index is up ~19% in
4 November 2025
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UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

Stock Performance: Skyrockets and Crashes UniQure’s stock has been on a wild ride in 2025. After starting the year in the mid-teens, QURE shares skyrocketed through mid-2025 on hopes for its Huntington’s gene therapy. The rally hit a fever pitch in late September when Phase 1/2 trial data showed a remarkable 75% reduction in disease progression with AMT-130 – news that caused the stock to surge almost 200% that month reuters.com. By late October, QURE was hovering around $68–$70, up roughly 300–500% from spring levels. However, in the past few days the stock’s momentum sharply reversed. On Monday, Nov 3,
3 November 2025
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Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Spruce Biosciences (SPRB) Skyrockets 1,300% on FDA Breakthrough News – Experts Weigh In

What to Know Before Markets Open on October 20, 2025 FDA Breakthrough News Ignites Rally Spruce Biosciences’ meteoric rise began with a game-changing regulatory win. On October 6, the company announced that the FDA had granted Breakthrough Therapy Designation (BTD) to its lead drug, tralesinidase alfa (TA-ERT) ts2.tech. TA-ERT is an experimental enzyme replacement therapy targeting Sanfilippo Syndrome Type B (also known as MPS IIIB) – a rare, inherited lysosomal storage disease that causes severe neurological decline in children stocktwits.com. The FDA’s BTD endorsement signals that early data for TA-ERT show “substantial improvement” over existing options for this deadly disease,
19 October 2025
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Kezar Life Sciences Stock Soars 40% After FDA Setback Sparks Strategic Shake-Up

Kezar Life Sciences Stock Soars 40% After FDA Setback Sparks Strategic Shake-Up

FDA Setback Triggers Strategic Review Kezar Life Sciences revealed a major regulatory setback for its lead drug and immediately pivoted to consider strategic alternatives. In an October 16 press release, the South San Francisco company announced it failed to reach alignment with the U.S. Food and Drug Administration on the design of a pivotal trial for zetomipzomib in autoimmune hepatitis (AIH) ca.investing.com. The FDA abruptly canceled a Type C meeting that was scheduled for Q4 2025 to discuss Kezar’s proposed Phase 3 trial, and instead requested a new standalone study to characterize zetomipzomib’s pharmacokinetics in patients with severe liver impairment
17 October 2025
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Disc Medicine (IRON) Stock Soars on FDA Fast-Track News as Analysts Boost Targets

Disc Medicine (IRON) Stock Soars on FDA Fast-Track News as Analysts Boost Targets

FDA Voucher Ignites IRON Stock Rally Disc Medicine’s stock price (NASDAQ: IRON) spiked dramatically in mid-October 2025 after news of the FDA voucher, vaulting from the mid-$70s to the low-$90s in a single day gurufocus.com. On Friday (Oct. 17), IRON opened around $85 and surged to an intraday high of $92.50 before closing at $93.00, marking a ~25% jump on the day stockanalysis.com. This leap capped a steady uptrend over the past month – the shares were trading near $60 in early September and gradually climbed into the $70s as anticipation built around bitopertin’s NDA filing and review stockanalysis.com stockanalysis.com.
17 October 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Sarepta Therapeutics Stock Skyrockets After FDA U-Turn – Gene Therapy Drama Explained

Stock Performance: Wild Swings from Deaths to Resumption SRPT has been a roller-coaster. In early 2025, Sarepta’s shares were largely pummeled by the DMD gene-therapy crisis. After two Duchenne patients (non-ambulatory teens) died in June and FDA urged a full pause, the stock plunged to decade lows (losing ~85% YTD) nasdaq.com biospace.com. (William Blair analysts warned this was a “worst-case scenario” that could “negatively affect patient interest in Elevidys” biospace.com.) On July 17, Sarepta partially paused Elevidys for all patients, and FDA did as well – shares briefly hit the low teens. Then, on July 28 FDA green-lit Elevidys resumption
3 October 2025
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Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

Researchers in China unveiled a hydrogel-based “smart” wound dressing that speeds diabetic ulcer healing, with a single application achieving about 90% wound closure in 12 days by delivering microRNA-loaded vesicles that suppress the vessel-growth inhibitor TSP-1. A Swedish study published August 8 identified 87 DNA methylation sites in blood from 752 newly diagnosed diabetics followed for seven years, creating a score that predicted cardiovascular outcomes with 96% accuracy for identifying low-risk patients. A natural compound in maple tree syrup, epicatechin gallate (ECG), blocked Streptococcus mutans biofilm formation in lab tests, suggesting potential as a safe plaque-preventing agent in mouthwash or
10 August 2025
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