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Qfitlia Approved as First US Therapy for Hemophilia A/B with or without Inhibitors
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of…
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Imfinzi Approved as First Perioperative Immunotherapy for Bladder Cancer
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery…
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Lexicon Pharmaceuticals Signs Exclusive License Agreement with Novo Nordisk for LX9851
Lexicon Pharmaceuticals, Inc. announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development…
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Ionis Expands Partnership with Sobi for Olezarsen Commercialization Outside the U.S.
Ionis Pharmaceuticals, Inc. announced that it has entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada and China to…
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European Commission Approves Merck’s CAPVAXIVE for Pneumococcal Disease in Adults
Merck, known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active…
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FDA Grants Fast Track to Chlamydia Vaccine Candidate
The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the…
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United Laboratories & Novo Nordisk Announce Exclusive License for UBT251
The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology…
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FDA Approves Blujepa for Uncomplicated UTIs in Women and Kids 12+
GSK plc announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40…
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Novartis Gains FDA Approval for Fabhalta in C3G
Novartis today announced that oral Fabhalta (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce…
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Oxford BioTherapeutics Partners with Roche on Cancer Targets
Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies, announced a multi-year…
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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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