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EMA/FDA

FDA granted Breakthrough Therapy designation for lonafarnib

Eiger announces Breakthrough Therapy designation granted by FDA for Lonafarnib for treatment of hepatitis delta virus (HDV) infection – Phase 3 HDV “D-LIVR” international study initiating PALO ALTO, Calif., December…

FDA announces pilot program with WHO to expedite review of HIV drug applications

“Since the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently…

DELSTRIGO and PIFELTRO approved in Europe

European Commission approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and PIFELTRO™ (doravirine), an NNRTI, both for the treatment…

EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision

A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised procedure…

ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV

Priority review voucher used with NDA submission with anticipated target action date of six months London, UK 17 October 2018 – ViiV Healthcare today announced it has submitted a New…

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

The U.S. Food and Drug Administration today (October 5) approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to…

Update on EMA’s Brexit preparedness

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018. The temporary…

EMA panel backs two new HIV drugs

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck Sharp…

EMA: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108 The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAPs) for which, based on current…

ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV

London, UK 14 September 2018 – ViiV Healthcare today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG)…

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