AAPL324.53-0.61 (-0.19%) ▼|ABBV258.72-1.27 (-0.49%) ▼|ABT112.09+3.16 (+2.90%) ▲|ACN186.16-1.93 (-1.03%) ▼|ADBE282.68-3.41 (-1.19%) ▼|AMAT437.13-4.73 (-1.07%) ▼|AMD457.95-1.66 (-0.36%) ▼|AMGN437.01-1.11 (-0.25%) ▼|AMT174.30-1.72 (-0.98%) ▼|AMZN255.10+0.18 (+0.07%) ▲|AVGO369.77+0.09 (+0.02%) ▲|AXP329.95+5.76 (+1.78%) ▲|BA210.00+4.34 (+2.11%) ▲|BAC63.18+1.19 (+1.91%) ▲|BKNG198.67+2.98 (+1.52%) ▲|BLK1,123.43-4.67 (-0.41%) ▼|BMY67.06+0.14 (+0.21%) ▲|BNY161.84+1.33 (+0.83%) ▲|BRK-B507.73+5.40 (+1.08%) ▲|C134.93+2.39 (+1.80%) ▲|CAT785.34+6.18 (+0.79%) ▲|CL90.45+0.82 (+0.91%) ▲|CMCSA27.06+0.76 (+2.89%) ▲|COF218.64+7.30 (+3.45%) ▲|COP136.28+0.09 (+0.07%) ▲|COST934.82-5.14 (-0.55%) ▼|CRM255.33-2.79 (-1.08%) ▼|CSCO109.01-0.73 (-0.67%) ▼|CVS98.41+0.81 (+0.83%) ▲|CVX211.71+0.66 (+0.31%) ▲|DE686.10+10.02 (+1.48%) ▲|DHR210.09+3.16 (+1.52%) ▲|DIS108.68+2.46 (+2.31%) ▲|DUK120.34-0.05 (-0.04%) ▼|EMR149.61+1.98 (+1.34%) ▲|FDX322.30-2.58 (-0.79%) ▼|GD363.41-6.01 (-1.63%) ▼|GE332.17+1.08 (+0.33%) 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▲|BAC63.18+1.19 (+1.91%) ▲|BKNG198.67+2.98 (+1.52%) ▲|BLK1,123.43-4.67 (-0.41%) ▼|BMY67.06+0.14 (+0.21%) ▲|BNY161.84+1.33 (+0.83%) ▲|BRK-B507.73+5.40 (+1.08%) ▲|C134.93+2.39 (+1.80%) ▲|CAT785.34+6.18 (+0.79%) ▲|CL90.45+0.82 (+0.91%) ▲|CMCSA27.06+0.76 (+2.89%) ▲|COF218.64+7.30 (+3.45%) ▲|COP136.28+0.09 (+0.07%) ▲|COST934.82-5.14 (-0.55%) ▼|CRM255.33-2.79 (-1.08%) ▼|CSCO109.01-0.73 (-0.67%) ▼|CVS98.41+0.81 (+0.83%) ▲|CVX211.71+0.66 (+0.31%) ▲|DE686.10+10.02 (+1.48%) ▲|DHR210.09+3.16 (+1.52%) ▲|DIS108.68+2.46 (+2.31%) ▲|DUK120.34-0.05 (-0.04%) ▼|EMR149.61+1.98 (+1.34%) ▲|FDX322.30-2.58 (-0.79%) ▼|GD363.41-6.01 (-1.63%) ▼|GE332.17+1.08 (+0.33%) ▲|GEV901.08+2.55 (+0.28%) ▲|GILD150.10+0.18 (+0.12%) ▲|GM85.09-0.54 (-0.63%) ▼|GOOG333.66+1.63 (+0.49%) ▲|GOOGL337.29+2.27 (+0.68%) ▲|GS1,007.58+5.02 (+0.50%) ▲|HD320.31+0.54 (+0.17%) ▲|HON208.39-1.59 (-0.76%) ▼|IBM230.57-0.83 (-0.36%) ▼|INTC89.54+0.57 (+0.64%) ▲|INTU343.17-1.77 (-0.51%) ▼|ISRG380.16+10.91 (+2.95%) ▲|JNJ274.41+3.22 (+1.19%) ▲|JPM358.82+3.87 (+1.09%) ▲|KO88.78+0.78 (+0.89%) ▲|LIN488.69+1.93 (+0.40%) ▲|LLY1,174.01+14.01 (+1.21%) ▲|LMT533.01-11.50 (-2.11%) ▼|LOW201.48+1.43 (+0.71%) ▲|LRCX287.10-3.10 (-1.07%) ▼|MA589.42+8.32 (+1.43%) ▲|MCD262.52+1.41 (+0.54%) ▲|MDLZ62.37+0.76 (+1.23%) ▲|MDT94.26+2.22 (+2.41%) ▲|META595.84+17.30 (+2.99%) ▲|MMM169.96-0.28 (-0.17%) ▼|MO69.49-0.08 (-0.12%) ▼|MRK150.63+0.77 (+0.51%) ▲|MS213.63+2.59 (+1.23%) ▲|MSFT497.62-3.40 (-0.68%) ▼|MU940.77+7.33 (+0.78%) ▲|NEE82.77-0.16 (-0.19%) ▼|NFLX82.68+1.87 (+2.31%) ▲|NKE38.48+0.36 (+0.94%) ▲|NOW138.12-4.78 (-3.35%) ▼|NVDA226.23+8.79 (+4.04%) ▲|ORCL145.44+4.12 (+2.92%) ▲|PEP141.48+1.69 (+1.21%) ▲|PFE28.86+0.31 (+1.07%) ▲|PG147.58+1.37 (+0.94%) ▲|PLTR170.04-9.88 (-5.49%) ▼|PM188.16+1.01 (+0.54%) ▲|QCOM169.42+2.81 (+1.69%) ▲|RTX202.29-2.87 (-1.40%) ▼|SBUX107.60+1.45 (+1.37%) ▲|SCHW109.43+1.15 (+1.06%) ▲|SO88.02-0.07 (-0.08%) ▼|SPG210.21-1.66 (-0.78%) ▼|T26.36+0.36 (+1.37%) ▲|TMO607.30+6.80 (+1.13%) ▲|TMUS187.48+5.32 (+2.92%) ▲|TSLA355.30-0.79 (-0.22%) ▼|TXN256.70+3.36 (+1.32%) ▲|UBER76.60+1.36 (+1.80%) ▲|UNH400.09+3.79 (+0.96%) ▲|UNP290.67+0.05 (+0.02%) ▲|UPS103.26+0.60 (+0.58%) ▲|USB62.60+1.39 (+2.26%) ▲|V379.26+6.59 (+1.77%) ▲|VZ50.69+0.39 (+0.77%) ▲|WFC89.67+2.63 (+3.02%) ▲|WMT106.05+0.13 (+0.12%) ▲|XOM163.07-1.49 (-0.90%) ▼|
21.3 C
New York
Wednesday, September 2, 2026

Tag: FDA

newssourceFORcompanyinformationcontent1releasesmarket

Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD

Landmark FDA Approval Is an Important Milestone in Retina Care, Bringing Patients and Physicians an Ophthalmic Bevacizumab Developed Specifically for the Eye Following Years of Rigorous Clinical and Regulatory Evaluation

FDA Approves TYLENOL® with Naproxen, the First and Only Over-the-Counter Fixed-Dose Combination of Acetaminophen (650 mg) and Naproxen Sodium (220 mg)

TYLENOL® with Naproxen is a clinically proven, opioid-free, fixed-dose combination that begins working in under 30 minutes and provides 12 hours of pain relief...

Save Remote Monitoring Coalition Launches to Oppose Flawed CMS Proposals in the 2027 Physician Fee Schedule

Providers and remote monitoring companies unite to defend a proven Medicare benefit and to demand real enforcement against bad actors in place of structural...

Harbour BioMed Announces Positive Profit Alert for 2026 Interim Results, Marking Seventh Consecutive Profitable Half-Year as Platform-Based Advantages Drive Sustainable Growth

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 23, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery...

Cellular Medicine Association: “The Billionaires’ Vagina Club” Reveals a Divide in Modern Medicine

Why women's sexual-health innovation is increasingly shaped by physician judgment, scientific evidence, and patient choice—not insurance coverage alone. FAIRHOPE, Ala., July 22, 2026 /PRNewswire/...

World-Premier Cancer Center Sheba Medical Center Selects Entolimod for Clinical Trial, Potentially Expanding Valion Bio into the Multi-Billion-Dollar Neutropenia Market

Sheba Medical Center, which is ranked the #7 hospital in the world,...

Appili Therapeutics Reports Fiscal Year 2026 Financial and Operational Results

LIKMEZ® (ATI-1501) commercial momentum building in U.S. market

US$40 million NIAID award supporting VXV-01 advancement through Phase 1

SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease

SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis Approval includes a...

Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of...

WILMETTE, Ill., June 26, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate choline, TMC) will be presented at the 12th Congress of the European Academy of Neurology (EAN 2026), June 27–30, 2026, in Geneva, Switzerland. These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus standard of care.

Larimar Therapeutics Announces Investor Event on the Nomlabofusp Program for Friedreich’s Ataxia

BALA CYNWYD, Pa., June 26, 2026 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host an investor event to discuss updates for the Company’s nomlabofusp clinical development program including a regulatory update and data from the ongoing long-term open label study for the treatment of Friedreich’s ataxia on Monday, June 29, 2026 at 7:45 am ET.

Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)

BEDFORD, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs). 

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...

Siren Biotechnology Awarded $8M in Non-Dilutive Grant Funding from the California Institute for Regenerative Medicine (CIRM) to Support Clinical Development of SRN-101 in High-Grade...

Siren Biotechnology awarded $8M in grant funding from the California Institute for Regenerative Medicine (CIRM) to support clinical development of SRN-101

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