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FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older…
GSK plc announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract…
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Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi…
Bristol Myers Squibb announced that the European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR)…
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FDA Approves Genentech’s Polivy in Combination With R-CHP for People With Certain Types of…
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab),…
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AbbVie Announces European Commission Approval of RINVOQ (upadacitinib) for the Treatment of…
AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ (upadacitinib, 45 mg and 15 mg and 30 mg ) as the first oral Janus Kinase (JAK) inhibitor for the…
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BIO-TECHNE AND LUNAPHORE ESTABLISH STRATEGIC PARTNERSHIP TO DEVELOP THE FIRST FULLY AUTOMATED…
Bio-Techne, a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, and Lunaphore, a Swiss life sciences…
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Biogen Exercises Option with Denali to Develop and Commercialize Antibody Transport Vehicle Program…
Biogen Inc. and Denali Therapeutics Inc. announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). Accumulation…
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Teva’s Digital Health Collaboration with Rimidi Expands to Include Respiratory Monitoring Program…
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that a respiratory patient monitoring program using data from Teva’s Digihaler System has been…
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Roche announces collaboration with Lilly to enhance early diagnosis of Alzheimer’s disease
Roche announced that it has entered into a collaboration with Eli Lilly and Company to support the development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative…
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Gilead Exercises Option to License Nurix’s IRAK4 Targeted Protein Degrader Development Candidate,…
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. announced that Gilead has exercised its option to exclusively license Nurix’s investigational targeted protein degrader molecule…
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BioNTech and OncoC4 Announce Strategic Collaboration to Co-Develop and Commercialize Novel…
BioNTech SE and OncoC4, Inc. announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation…
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Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade…
Novartis announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of pediatric patients 1 year of age…
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Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent…
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’…
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Ipsen completes acquisition of Albireo, expanding the scope of its Rare Disease portfolio
Ipsen announced it has completed the acquisition of Albireo Pharma, Inc., a leading innovator in bile-acid modulators to treat rare liver conditions. The acquisition enriches Ipsen’s…
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The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial…
Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) today announced the launch of the…
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Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation…
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Pfizer’s RSV Maternal Vaccine Candidate BLA Accepted by FDA for Priority Review
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine…
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Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary
Takeda announced that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. (“Lakshmi”) from Nimbus Therapeutics, LLC (“Nimbus”), on February 8, 2023 (EST), as set forth…
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EYLEA (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with…
Regeneron Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA (aflibercept) Injection to treat preterm infants with retinopathy of…
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Forxiga approved in the EU for the treatment of symptomatic chronic heart failure
Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full…
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Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on…
GSK plc announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the…
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