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U.S. intelligence officials have informed senators that China-based biotech WuXi AppTec transferred an American client’s intellectual property to the Chinese government without consent, reports Reuters.
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Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
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Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
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Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
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Sanders says he wants Novo Nordisk to “do the right thing” and lower the costs of Ozempic and Wegovy. But only the Inflation Reduction Act can achieve that.
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The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs.
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Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints.
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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib
3/29/2024
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company announced that the first patient in China has been dosed in the Phase 1b clinical study of the combination of InnoCare’s novel SHP2.
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Alebund's Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
3/29/2024
Alebund Pharmaceuticals ("Alebund" or the "Company") announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
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Maverix Medical Closes Acquisition of Cirrus Bio as Foundation for Diagnostics Platform in Lung Cancer
3/29/2024
Maverix Medical, a dedicated lung cancer platform established by Ajax Health, KKR, and Hologic, Inc., today announced the acquisition of Cirrus Bio for an undisclosed amount.
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PassPort Technologies, Inc. Announces Positive Interim Phase I Results of Zolmitriptan Transdermal Microporation System for the Treatment of Acute Migraine
3/29/2024
PassPort Technologies, Inc. (PPTI), based in San Diego, a clinical-stage drug and medical device development company, today announced positive interim results from the Phase 1 (Part A) clinical trial of Zolmitriptan PassPort® utilizing its proprietary transdermal microporation system for the treatment of acute migraine.
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Key Proteo Submits De Novo Application to FDA for its First Newborn Screening Kit
3/29/2024
Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) for its first in vitro diagnostic Key Proteo Newborn Screening Kit.
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73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis
3/29/2024
Biostar Pharma, Inc. announced today that their core pipeline product utidelone injectable (UTD1) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of breast cancer brain metastasis (BCBM).
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Laborie Medical Technologies Invests in iO Urology and the CarePath Uroflow Device
3/29/2024
Leading diagnostic and therapeutic medical technology company Laborie Medical Technologies Corp. (Laborie) announced its investment in iO Urology, a venture-backed medical technology company that developed CarePath® an at-home, handheld uroflow device that is FDA-approved and has been utilized in multiple urology clinics in the U.S.
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UPSHER-SMITH LAUNCHES METHIMAZOLE TABLETS, USP
3/29/2024
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg. The Methimazole Tablet market had U.S. sales of approximately $36.8 million for the 12 months ending December 2023 according to IQVIA.
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Guardion Health Sciences Announces Financial Results for the Year Ended December 31, 2023
3/29/2024
Guardion Health Sciences, Inc. announced its financial results for the year ended December 31, 2023.
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Adlai Nortye Announces Appointment of Dr. Archie Tse as the Head of Research & Development
3/29/2024
Adlai Nortye Ltd. announced the appointment of Dr. Archie Tse as Head of Research & Development, reporting to Mr. Carsten Lu, CEO and Chairman of Adlai Nortye, effective March 29th, 2024.