Specialty Pharma Journal Specialty, Precision & Technology
GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) granted a priority …
Read More »FDA Grants Priority Review to GSK’s Belantamab Mafodotin for Treatment of Relapsed or Refractory Multiple Myeloma
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Genprex Receives Fast Track Designation from the FDA for its Gene Therapy that Targets Lung Cancer
AUSTIN, Texas & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy …
Read More »FDA Accepts and Grants Priority Review for Lynparza sNDA in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and …
Read More »BeiGene’s Tislelizumab Meets its Primary Endpoint in Interim Analysis of Phase 3 Trial in Patients with First-Line Squamous NSCLC
BEIJING, China, and CAMBRIDGE, Mass., Jan. 21, 2020 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), …
Read More »FDA Grants Orphan Drug Designation to OBI Pharma’s Investigational Gastric Cancer Treatment
TAIPEI, Taiwan, Jan. 21, 2020 /PRNewswire/ — OBI Pharma, Inc., a Taiwan biopharma company (TPEx: …
Read More »FDA Approves Ozempic to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes and Known Heart Disease
PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) …
Read More »BioNTech to Acquire Neon to Strengthen Global Leadership Position in T Cell Therapies
MAINZ, Germany and CAMBRIDGE, Mass., Jan. 16, 2020 (GLOBE NEWSWIRE) — BioNTech (Nasdaq: BNTX, “BioNTech”) …
Read More »FDA Grants Fast Track Designation to Arena’s APD418 for Patients with Decompensated Heart Failure
SAN DIEGO, Jan. 16, 2020 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that …
Read More »BerGenBio Meets Efficacy Endpoint for First Stage of Phase II Trial with Bemcentinib in Combination with Keytruda in NSCLC
BERGEN, Norway, Jan. 15, 2020 /PRNewswire/ — BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company …
Read More »ArcherDX Personalized Cancer Monitoring Technology Designated by FDA as Breakthrough Device
BOULDER, Colo., Jan. 14, 2020 /PRNewswire/ — ArcherDX, Inc., today announced it has received Breakthrough …
Read More »New Head-to-Head Phase 3 Data Show Skyrizi Superior to Cosentyx in Adults with Moderate to Severe Plaque Psoriasis
NORTH CHICAGO, Ill., Jan. 14, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced …
Read More »Personal Genome Diagnostics and Eisai Partner to Develop Comprehensive Liquid Biopsy Biomarker Discovery Solution
BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, is partnering with Eisai …
Read More »QIAGEN Builds on Global Collaboration With Amgen for Companion Diagnostic Development in Non-small Cell Lung Cancer
Hilden, Germany and Germantown, Maryland, January 13, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) …
Read More »FDA Grants Priority Review to Clovis Oncology’s Rubraca for Treatment of Advanced Prostate Cancer
BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug …
Read More »FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo Plus Yervoy in First-Line NSCLC
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) …
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