Highlights
FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
LONDON--(BUSINESS WIRE) April 08, 2019 --ViiV Healthcare today announced that the US Food and Drug Administration (FDA)
Using Agile Values for Medical Device Development
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
nlZogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepl
EMERYVILLE, Calif., April 08, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company dev
Targeted Protein Degradation Summit, October 22-24 2019, Boston, USA
The 2nd TPD 2019 is a specifically dedicated scientific and networking forum for large pharma, innovative biotech and re
Australia Proposes New Device Classifications to Align With EU Regs
nl Australia’s TGA released five new draft guidances that propose changes to the classification of numer
CDRH Warns of Device Shortages Following Sterilizer’s Suspension
nl CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages followi
EC Issues Guidance on Eudamed, Nomenclature System
nl The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices)
MITA Urges FDA to Clarify Servicing And Remanufacturing Differences
nl The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes
Categories refined for the 2019 PharmaTimes Sales Awards
The categories for the 2019 PharmaTimes Sales Awards have been refined to greater reflect current trends and changes in
Diagnosis and management of idiopathic pulmonary fibrosis
Pharmacists can play a vital role in the diagnosis and management of idiopathic pulmonary fibrosis, and can help improve
AZ's Fasenra shows promise in hypereosinophilic syndrome
The drug is AstraZeneca’s first respiratory biologic.
Myriad, AstraZeneca and MSD expand collaboration
The expansion will use BRACAnalysis CDx to identify germline BRCA mutations.