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Salipro Biotech and Boehringer Ingelheim Strike Research and License Deal to Boost Pipeline Programs
Salipro Biotech AB, a Swedish biotech company specialising in the stabilisation of challenging drug targets, announced a research and license agreement with Boehringer Ingelheim to…
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Zealand Pharma and Roche Partner to Co-Develop Petrelintide for Overweight and Obesity Treatment
Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces a global collaboration and license agreement with…
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Merck Reports Positive Phase 3 Data for Doravirine/Islatravir (DOR/ISL) in HIV-1 Treatment
Merck, known as MSD outside of the United States and Canada, announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral,…
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Novo Nordisk Launches NovoCare Pharmacy, Reduces Wegovy Cost to $499/month
As part of its ongoing efforts to ensure patients who need Wegovy (semaglutide) injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg can access it, Novo Nordisk launched NovoCare…
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Astellas and YASKAWA Form Joint Venture for Cell Therapy Manufacturing
Astellas Pharma Inc. and YASKAWA Electric Corporation signed a definitive agreement to establish a joint venture for the development of a cell therapy product manufacturing platform…
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AbbVie and Gubra Strike License Deal to Develop Amylin Analog for Obesity
AbbVie and Gubra A/S, a company specializing in preclinical contract research services and peptide-based drug discovery within metabolic and fibrotic diseases, announced a license…
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CHMP Recommends EU Approval of Imfinzi-based Regimen for Resectable NSCLC
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU) for the treatment of adults with resectable non-small…
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FDA Approves Genentech’s TNKase for Acute Ischemic Stroke in Adults
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the…
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FDA Grants Priority Review to Sobi’s sBLA for Gamifant (emapalumab-lzsg)
Sobi announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg) for use in adult and…
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FDA Accepts BLA for Odronextamab in Treating Relapsed/Refractory Follicular Lymphoma
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for…
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Lilly to Exceed $50 Billion in U.S. Manufacturing Investment, Doubling Since 2020
Eli Lilly and Company announced at a press conference in Washington, D.C., plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical…
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FDA Accepts BMS’ SBLAs for Opdivo + Yervoy in MSI-High, MMR-D Cancer
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy …
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EMA Validates Gilead’s Application for Twice-Yearly Lenacapavir as HIV Prevention
Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and…
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Teva and Alvotech Launch SELARSDI Injection in the U.S.
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar…
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Boehringer’s Zongertinib Gets U.S. FDA Priority Review for HER2-Mutant Advanced NSCLC
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of…
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FDA Accepts Dupixent sBLA for Bullous Pemphigoid Treatment under Priority Review
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous…
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FDA Accepts Gilead’s NDA for Twice-Yearly Lenacapavir for HIV Prevention
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly…
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Nemluvio Approved in EU for Atopic Dermatitis and Prurigo Nodularis
Galderma announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now…
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Lundbeck’s Amlenetug for MSA Receives FDA Fast Track Designation
The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently…
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AbbVie and Xilio Therapeutics Partner to Develop Tumor-Activated Immunotherapies
AbbVie and Xilio Therapeutics, Inc. a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, announced…
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