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EMA/FDA

CytoDyn submits first part of biologics license application to FDA for leronlimab (PRO 140)

CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV -- FDA previously granted Rolling Review for…

EMA now operating from Amsterdam

As of today (March 11), EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its staff will gradually move…

Booklet on EMA pre-submission and assessment processes

The European Medicines Agency (EMA) has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to…

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…

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