FDA+ channel feed – Endpoints News

FDA+ channel feed

DBV lays off employees, scales down programs after receiving no word from FDA

5 years ago

Novartis yanks application from the EMA after regulators say researchers never proved efficacy of their $3.4B dry eye drug

5 years ago

After 2 delays, Zogenix nabs FDA approval for epilepsy drug, sets price at 3X its GW Pharma competitor

5 years ago

AbbVie’s first post-merger Allergan drug pitch strikes out with the FDA as regulators turn thumbs down on Lucentis challenger

5 years ago

FDA OKs Merck’s heavyweight Keytruda for cancer niche — triggering title fight with the street brawlers at Regeneron

5 years ago

FDA lifts partial hold on cancer drug after Innate resolves manufacturing issue

5 years ago

Hahn testifies on Covid-19 response, says FDA on target to hit user fee goals

5 years ago

Myovant readies NDA #3 as relugolix sails to its 5th positive PhIII — this time in endometriosis

5 years ago

Lawmakers ask FDA to outline Covid-19 vaccine approval process

5 years ago

Evoke Pharma finally lands approval for lead and only drug

5 years ago

FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions

5 years ago

Epizyme hits the ground running with second — and crucial — OK for Tazverik, in follicular lymphoma

5 years ago

Hours after blockbuster patent win, Mylan asks the FDA to speed up an OK to market a generic to Biogen’s Tecfidera

5 years ago

FDA offers statistical guidance for trials impacted by Covid-19

5 years ago

UK investigators say a drug reduced Covid-19 deaths for the first time. The world ponders what to do next

5 years ago

FDA warns Takeda over aseptic processing, inadequate investigations

5 years ago

FDA approves first therapeutic video game

5 years ago

Jazz Pharma’s $1B bet pays off with accelerated lung cancer approval

5 years ago

FDA weighs post-pandemic challenges at BIO meeting

5 years ago

Apellis counters Alexion’s critique, clears up FDA questions as blockbuster decision looms

5 years ago

AstraZeneca spinoff scores maiden FDA approval, where it will field Alexion competition and an imminent Roche rival

5 years ago

Peter Marks dishes on Covid-19 vaccine development at BIO

5 years ago

FDA defends its oversight of foreign drugs amid Senate, GAO criticism

5 years ago

FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review

5 years ago

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