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Medical Innovations News 9 August 2025 - 17 November 2025

Tonix Pharmaceuticals (TNXP) Jumps as TONMYA, First New Fibromyalgia Drug in 15 Years, Hits U.S. Pharmacies – November 17, 2025

Tonix Pharmaceuticals (TNXP) Jumps as TONMYA, First New Fibromyalgia Drug in 15 Years, Hits U.S. Pharmacies – November 17, 2025

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) moved sharply higher today after the company confirmed that TONMYA™ (cyclobenzaprine HCl sublingual tablets), its newly approved fibromyalgia treatment, is now commercially available by prescription across the United States. GlobeNewswire+1 TONMYA Officially Launches in the U.S. Tonix announced at 7:00 a.m. EST that TONMYA is available for pharmacy ordering nationwide and can now be prescribed for adults with fibromyalgia. GlobeNewswire The drug is: TONMYA became the first new FDA‑approved therapy for fibromyalgia in more than 15 years when regulators cleared it on August 15, 2025, based on two pivotal Phase 3 trials involving nearly
17 November 2025
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GRAIL Inc. Stock Rises on Samsung Partnership and Cancer-Test News

GRAIL Stock Rockets on Samsung Mega-Deal and Cancer Test Breakthrough

Samsung Alliance Triggers Record Rally GRAIL’s stock price exploded after the company announced a strategic alliance with Samsung on October 16. Under the deal, Samsung C&T will invest $110 million in GRAIL and become the exclusive distributor of the Galleri multi-cancer blood test in South Korea, with rights to expand into Japan and Singapore ts2.tech. Samsung Electronics is also participating and plans to explore AI and health-data collaborations with GRAIL ts2.tech. This marks a major vote of confidence from one of Asia’s largest conglomerates. The partnership is expected to close by early 2026 (pending conditions) and gives GRAIL a powerful commercialization
20 October 2025
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Biotech Breakthrough: GRAIL (GRAL) Stock Surges on New Cancer-Detection Data

GRAIL (GRAL) Rockets to Record High on Samsung Mega-Deal and Cancer Test Breakthrough

Samsung Partnership Sparks Stock Surge GRAIL, Inc. (NASDAQ: GRAL) shares soared to record highs this week after the company announced a strategic collaboration with Samsung. On October 16, GRAIL revealed a binding agreement in which Samsung C&T and Samsung Electronics will invest $110 million into GRAIL at $70.05 per share ts2.tech. In return, Samsung C&T gains exclusive rights to distribute GRAIL’s Galleri multi-cancer early detection blood test in South Korea, with plans to expand to Japan and Singapore ts2.tech. Samsung Electronics will explore technology tie-ups, integrating its digital health platforms and AI with GRAIL’s cancer-detection technology tradingview.com prnewswire.com. Investors cheered the
17 October 2025
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Femasys (FEMY) Rockets on Fertility Breakthroughs and FDA Milestones – What’s Behind the Surge?

Femasys (FEMY) Rockets on Fertility Breakthroughs and FDA Milestones – What’s Behind the Surge?

FEMY Stock Soars on Fertility Buzz Femasys stock has been on a rollercoaster ride in recent sessions. As of October 17, 2025, FEMY traded around the mid-$0.70s per share – more than double its price just a few weeks prior, and well off its 52-week low near $0.31 ts2.tech. On October 16, the stock spiked dramatically: opening near $0.55, it rallied to an intraday high of $0.84 (+52%) before settling at $0.745 (+35%) by the close finance.yahoo.com. This explosive move came amid unusually heavy volume (tens of millions of shares traded, versus ~7 million on a typical day) stockinvest.us, indicating
17 October 2025
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MIRA Pharma Stock Skyrockets 100% Overnight as New Pain Drug Outshines Morphine

MIRA Pharma Stock Skyrockets 100% Overnight as New Pain Drug Outshines Morphine

Stock Soars on Breakthrough Announcement MIRA Pharmaceuticals’ stock price skyrocketed overnight on the back of surprising good news. The relatively obscure biotech – which trades on the Nasdaq Capital Market under ticker MIRA – closed Wednesday, Oct. 15 at $1.32 per share benzinga.com. That modest close (up less than 1% on the day) gave little hint of what was to come. After the market shut, MIRA stunned investors with a press release detailing remarkable lab results for its lead drug candidate. The reaction was immediate: shares surged 68.94% in after-hours trading, reaching $2.23 benzinga.com. And the rally didn’t stop there.
16 October 2025
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Biotech Breakthrough: GRAIL (GRAL) Stock Surges on New Cancer-Detection Data

Biotech Breakthrough: GRAIL (GRAL) Stock Surges on New Cancer-Detection Data

Analysis: GRAIL’s stock performance reflects a wave of optimism about its Galleri cancer-screening test and pending trial results. In late September it broke out to new highs, aided by momentum and positive chatter (e.g. a StocksToTrade report noted a 17.93% jump on Sept 29 as MCED excitement grew stockstotrade.com). The company itself is pushing the narrative: GRAIL President Dr. Josh Ofman proclaims Galleri’s data will usher in a “transformative era for cancer screening,” detecting cancers earlier “when they can be easier to treat and are potentially curable” grail.com. For context, GRAIL has a unique profile. It straddles biotech and diagnostics:
3 October 2025
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Biotech Breakthroughs & Pharma Shakeups – Global Health Roundup (Aug 20–21, 2025)

Biotech Breakthroughs & Pharma Shakeups – Global Health Roundup (Aug 20–21, 2025)

Industry & Corporate Developments Mergers, Acquisitions & Partnerships Regulatory & Drug Approval Updates Public Health & Policy Research & Clinical Breakthroughs Sources: Reuters, Politico, HealthLeaders, BioPharma Dive, FierceBiotech, Pharmaceutical Executive, Technology Networks, McGill University reuters.com reuters.com healthleadersmedia.com reuters.com fiercebiotech.com reuters.com reuters.com technologynetworks.com technologynetworks.com.
21 August 2025
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Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Wegovy (semaglutide) received FDA accelerated approval to treat metabolic dysfunction-associated steatohepatitis (MASH), becoming the first GLP-1 therapy cleared for MASH in a patient population estimated at about 5% of U.S. adults, based on part 1 of an ongoing trial showing liver health improvement. Tonix Pharmaceuticals’ Tonmya, or TNX-102 SL, was approved August 15 for fibromyalgia, the first new fibromyalgia therapy in 15 years, with two Phase 3 trials showing significantly reduced daily pain versus placebo at 14 weeks and a potential peak U.S. sales of about $800 million. Pfizer’s inclacumab, a P-selectin inhibitor acquired via the 2022 $5.4 billion Global
16 August 2025
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Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data onclive.com.) Clinical Trials & Research Breakthroughs Public Health & Policy Industry & Business Updates Sources: Key information and quotes in this report were drawn from Reuters news wires reuters.com reuters.com, official WHO releases who.int pharmabiz.com, and industry trade outlets including Fierce Biotech/Pharma fiercepharma.com fiercepharma.com and company statements. Each development is linked to its original source for further reading.
9 August 2025
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