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Pharma News for Merck, Roche, AbbVie, Abbisko Pfizer
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...

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Roche’s Vabysmo Third US Approval Spiced Up the Battle With Regeneron and Bayer’s Eylea

Roche’s Vabysmo secures a new FDA nod for retinal vein occlusion treatment, intensifying the competition with Regeneron and Bayer’s Eylea in the eye medication market. This approval for Vabysmo in RVO adds another shared medical indication for the competing eye medications. Vabysmo’s successful FDA approval for RVO...

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Pharma News for GSK, Roche, Eli Lilly, Coherus
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...

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Pharma News for Faron, Roche, Ergomed, Menarini
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333

FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...

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MedTech news for Eko. Haemonetics. Roche, Medtronic, Biodesix
GE HealthCare, DePuy Synthes Announced Collaboration; Eko Health Launched CORE 500 Digital Stethoscope; Haemonetics’s NexSys PCS Plasma Collection System; Roche’s Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays; Medtronic’s MiniMed 780G system; Biodesix’s VeriStrat Blood-Based Host Immune Classifier

GE HealthCare Announced Collaboration with DePuy Synthes to Bring Advanced 3D Precision Imaging Innovation to Spine Practices in the United States On June 21, 2023, GE HealthCare entered into a distribution agreement with DePuy Synthes, the Orthopaedics division of Johnson & Johnson, to bring GE HealthCare’s...

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Pharma News for GSK, Roche, Avita, Ipsen
FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap

GSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...

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Abbvie-Genmab’s EPKINLY Approval for DLBCL Treatment: The First CD20XCD3 Bispecific Antibody

Abbvie-Genmab’s EPKINLY, the first CD20XCD3 Bispecific Antibody gets US approval for Relapsed/Refractory DLBCL treatment. Roche’s Glofitamab is expected to garner benefits in Europe first. Let's have a glimpse of evolving DLBCL treatment landscape in Relapsed/Refractory setting and if bi-specific as a class can be...

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Roche’s CD79b ADC POLIVY: Attempt to Change DLBCL Treatment Space

In recent years, the field of oncology has witnessed a remarkable transformation thanks to the groundbreaking innovation of antibody-drug conjugates (ADCs). These game-changing molecules have three key components: an antibody drug, a potent cytotoxic payload, and a specialized linker protein that binds them togethe...

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Roche’s HER2-Positive Breast Cancer Treatment Franchise

For most of the last century, breast cancer was categorized only by its location in the body; as a result, treatment results varied significantly. Patients with metastatic HER2+ breast cancer were traditionally treated with conventional chemotherapy regimens until trastuzumab became available. In September 1998, th...

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Pharma news and updates for Roche, Acadia, Shorla Oncology, Calliditas, Mesoblast, Sanofi, Provention Bio
Sanofi to Acquire Provention Bio; USFDA Committee Votes in Favor Roche’s Polivy; FDA to Review Mesoblast’s GvHD Drug; FDA Approves Acadia’s Daybue ; FDA Approves Nelarabine Injection; Calliditas’s Nefecon Trial Reuslt in IgA Nephropathy

Sanofi to Acquire Provention Bio for USD 2.9 Billion Sanofi and Provention Bio, Inc., a publicly traded biopharmaceutical company based in the United States focused on intercepting and preventing immune-mediated diseases such as type 1 diabetes (T1D), have agreed to acquire Provention Bio, Inc. for $25.00 per sh...

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