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FDA Clears Roche's cobas® BV/CV Assay, Enabling Fast and Highly Accurate Diagnosis of Vaginitis

Roche announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and...

Erbitux® (cetuximab) in Combination with Encorafenib and FOLFOX Approved by the European Commission as a First-Line Treatment for BRAF V600E-Mutant Metastatic Colorectal Cancer

Merck, a leading global science and technology company, announced that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with...

Organon to Present New Analysis of VTAMA® (tapinarof) Cream, 1%

Organon a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that a new analysis of Phase 3 data evaluating VTAMA cream. The presentation includes a pooled post hoc analysis...

Ori Biotech and ImmuXell Announce Strategic Partnership and First Patient Dosed

Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, and ImmuXell Biotech, a Shanghai-based clinical-stage cell therapy company, announced their strategic partnership which began in December 2025. The milestone: the first...

Presentations Highlight Results on LEROCHOL® (lerodalcibep-liga) Announced by LIB Therapeutics

LIB Therapeutics Inc. (LIB), a privately-held, biopharmaceutical company with a recently approved novel, monthly, small-dose, third-generation PCSK9 inhibitor, LEROCHOL® (lerodalcibep-liga), announced results from two oral and two poster...

Digi-Tech Pharma & AI Conference 2026

The 9th Annual Digi-Tech Pharma & AI conference, a premier Pharmaceutical Technology Conference, brings with it even more interactive sessions, expert speakers, senior professionals and decision makers from leading pharma, bio-tech and healthcare...

Hologic to Present New Data Demonstrating the Clinical Impact of the Breast Cancer Index® Test on Extended Endocrine Therapy Decisions

Hologic, Inc. and its subsidiary, Biotheranostics, Inc., announced new data demonstrating how the Breast Cancer Index® (BCI™) Test results influence extended endocrine therapy decisions for patients with early-stage, hormone receptor-positive...

Galvanize Therapeutics receives FDA clearance for the Aliya EX Generator, expanding its Aliya Pulsed Electric Field portfolio

Galvanize Therapeutics, Inc., a commercial-stage medical technology company pioneering pulsed electric field (PEF) therapies for oncology and chronic lung disease, today announced that it received U.S. Food and Drug Administration 510(k) clearance...

A new real-world case series examines re-induction with ADSTILADRIN in clinical practice

Ferring Pharmaceuticals announced a new real-world case series demonstrating that re-induction with ADSTILADRIN® (nadofaragene firadenovec-vncg) resulted in complete responses (CR) in approximately 31% (4/13) of patients with high-risk Bacillus...

BioOra Limited and Wellington Zhaotai Therapies Limited (WZTL) Execute Heads of Terms to Accelerate Global Expansion of CAR T-Cell Therapy

BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, announced the signing of a binding Heads of Terms agreement with Wellingto. Zhaotai Therapies Limited (Wellington Zhaotai) under which...

Merck’s once-daily IDVYNSO™ (doravirine/islatravir) receives FDA approval

Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved IDVYNSO™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1...

ARUP Laboratories Establishes Innovation Central Laboratory to Accelerate Diagnostic Innovation for Biotechnology and Pharmaceutical Partners

ARUP Laboratories, a leader in diagnostic medicine and the largest nonprofit reference laboratory in the U.S., announced the launch of a new Innovation Central Laboratory to facilitate collaboration with pharmaceutical, biotechnology, and other...

PureTech Secures U.S. and EU Orphan Designations for Deupirfenidone (LYT-100) in IPF

PureTech Health plc a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, announced that the U.S. Food and Drug Administration (FDA) and European Commission have granted Orphan Drug...

New ECCO data demonstrate that subcutaneous infliximab (Remsima™ SC) recaptures and maintains disease control following a drug holiday

Celltrion, Inc. announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcerative colitis...

FDA Grants KORU Medical Systems 510(k) Clearance for RYSTIGGO® Delivery via FreedomEDGE® Infusion System

KORU Medical Systems, Inc. a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, announced that the Company received...

Clover Begins Phase 2 Clinical Evaluation of a Combination Respiratory Vaccine Targeting RSV, hMPV, and ± PIV3

Clover Biopharmaceuticals, Ltd. a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. Announced that enrollment of the first participants has...

GMA with MOVIVA®: Setting New Standards in Endoscopic Bariatric Treatment.

Just a few months after the world’s first Gastric Mucosal Ablation (GMA) case using MOVIVA® at the Policlinico Universitario Agostino Gemelli in Rome, clinical experience is rapidly expanding across Europe. With around 80 procedures performed...

Eisai Completes FDA Submission for LEQEMBI® IQLIK™ Subcutaneous Starting Dose.

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application...

Data on BIMZELX® (bimekizumab-bkzx) in Hidradenitis Suppurativa Showed Sustained Improvements in Pain and Draining Tunnel Resolution for Three Years

UCB, a global biopharmaceutical company, announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only medicine approved to selectively inhibit...

At the Heart Failure Society of America, Bayer will showcase new data for KERENDIA® (finerenone)

Bayer announced that data from across the KERENDIA® (finerenone) comprehensive clinical trial program will be presented at the Heart Failure Society of America (HFSA)’s. In July 2025, the U.S. Food and Drug Administration (FDA) approved a new...

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