FDA+ channel feed – Endpoints News

FDA+ channel feed

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

Canada’s drug price reforms delayed to 2021

5 years ago

Stephen Hahn: FDA will make some changes amid Covid-19 permanent

5 years ago

Roche nabs frontline OK for Avastin/Tecentriq in common liver cancer, besting an old Bayer drug

5 years ago

AbbVie wins an approval in uterine fibroid-associated heavy bleeding. Are rivals Myovant and ObsEva far behind?

5 years ago

FDA explains impact of Covid-19 on applications, formal meetings

5 years ago

GSK's asthma drug Nucala gets speedy review for rare blood disorder

5 years ago

Bristol Myers Squibb finally gets in the frontline NSCLC game dominated by Merck, adding a second Opdivo/Yervoy-based option

5 years ago

Alnylam nabs speedy review, setting up 3rd possible approval in 3 years

5 years ago

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