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EMA/FDA

FDA grants rolling review for CytoDyn’s planned BLA for investigational HIV therapy leronlimab (PRO 140)

First portion out of three portions of BLA to be filed in March VANCOUVER, Washington, March 04, 2019 -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO…

CytoDyn announces productive conference call with FDA regarding PRO 140

CytoDyn announces productive conference call with FDA regarding first BLA submission for leronlimab (PRO 140) combination therapy at 700 mg dose -- Successful interim results in the 700 mg monotherapy…

CHMP recommends for approval a generic version of atazanavir

At its January meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of atazanavir – Atazanavir Krka for the treatment of…

‘Female condom’ gets a genderless rebrand from FDA

At the end of last year, the U.S. Food and Drug Administration (FDA) approved new rules for "female" condoms that not only change the device's name but ease some other…

FDA accepts sNDAs for PIFELTRO™ and DELSTRIGO™

U.S. FDA accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) --Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed to…

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…