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BioSpace sat down with Niko Andre, M.D., Ph.D., global franchise head for hematology and immuno-oncology at AstraZeneca.
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Suliman anticipates filing an Investigational New Drug application with the FDA for the PCD asset this year, and next year filing one for the cystic fibrosis asset.
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The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.
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Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
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FDA rejected OPKO's once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.
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After decades of treating the big categories of heart disease – hypertension, for example – the ability to address the genetics of heart disease is within sight.
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TScan Therapeutics, Lyell, SQZ Biotech and others secured clearance from the U.S. Food and Drug Administration for their Investigational New Drug Application.
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The company submitted its application for AP-188 in early 2021, covering dosage details, formulation, and method of stroke rehabilitation.
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When presented with ORLADEYO, both patients and physicians recognized immediately the freedom gained with the once-daily prophylactic therapy and indicated a high willingness to use.
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It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
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MaaT Pharma decided today to end the Phase Ib CIMON study for MaaT03, the company's second drug candidate and first oral formulation in Phase 1b clinical trial, following positive interim engraftment data of the drug.
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The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie's proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
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January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
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Clinical Catch-Up: January 17-21
1/24/2022
Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look. -
The San Diego-based immunology company is locating and developing molecules where the mechanism of action has either been proven or makes sense.
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Oncopeptides gave no further details about its decision. However, the company has initiated a dialogue with the FDA to review the new data.
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dNovo Emerges From Stealth With Its Potential Cure for Hair Loss
1/24/2022
dNovo Inc., a Silicon Valley company developing a cure for hair loss by generating personalized hair stem cells, emerged from stealth and announced $2.7M in seed funding from Y Combinator, Felicis Ventures, Soma Capital, Yintai Investment Company LLC, and others.
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U.S. Food and Drug Administration Expands Deployment of Waters Corporation Software to Support its Medical Products Testing Labs
1/24/2022
Waters Corporation announced the U.S. Food and Drug Administration’s Office of Regulatory Affairs has purchased Waters™ Empower™ Chromatography Data Software and NuGenesis™ Laboratory Management Software, expanding its deployment of Waters’ software to support its medical products testing operations across its five field science laboratories.
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Smith+Nephew's PICO™ 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence
1/24/2022
Smith+Nephew, the global medical technology business, is pleased to announce new indications for use for its PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems.
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Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational New Drug Application for APS03118, a Next generation RET Original New Drug for Unlimited Cancers
1/24/2022
Applied Pharmaceutical Science, Inc., has recently announced the Investigational New Drug application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor, has been approved by the U.S. Food and Drug Administration.