FDA Advisory Committee Votes In Favor Of Approval Of Provention Bio’s Diabetes Med
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of recommending ap
AstraZeneca Announced Tagrisso Approved in EU in Early Lung Cancer
AstraZeneca's (NYSE: AZN) Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
Myriad Genetics Submits sPMA for myChoice CDx with Zejula in First-Line Platinum Responsive Advanced Ovarian Cancer
Myriad Genetics, Inc. (NASDAQ:MYGN) announced that it has submitted a supplementary premarket approval (sPMA) application to the U.S.…
Biohaven’s Verdiperstat Receives FDA ‘May Proceed’ Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General
Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) (“Biohaven” or the “Company”), a biopharmaceutical company with multiple late-stage neuroscience drug…
Chicken Sandwich Proxy Battle Playing Out Over MSG Use
McDonald’s Corp (NYSE:MCD) is testing a new chicken sandwich across three states and the National Owners Association is…
Baudax Bio Announces Feb. 20 PDUFA Date For Intravenous Meloxica
Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company focused on therapeutics for acute care settings, today announced that…
Axonics Announces FDA Approval Of Enhanced Neurostimulator Programmer
Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable…
EC Approves Roche’s Polivy for People with Previously Treated Aggressive Lymphoma
Roche (OTC:RHHBY) today announced that the European Commission has granted conditional marketing authorisation for Polivy® (polatuzumab vedotin), in…
Novartis Announces EU Approval of Mayzent for Adult Patients with Secondary Progressive MS with Active Disease
Novartis (NYSE:NVS) today announced the European Commission (EC) has approved Mayzent® (siponimod) for the treatment of adult patients…
Jazz Pharmaceuticals Receives EU Marketing Authorisation for Sunosi for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the European Commission approved Sunosi® (solriamfetol) to improve wakefulness and reduce…