FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA and EMA push ahead with joint efforts to kick-start pediatric cancer drug development plans

5 years ago

Looking to crack down on big biopharma M&A deals, FTC sues to block Illumina's $8B Grail acquisition

5 years ago

House Dems seek to overturn Trump-era rule that could gut FDA’s regulations

5 years ago

HHS regulatory agenda for 2021 is light on new proposed and final FDA rules

5 years ago

FDA busts Merck's Keytruda in triple-negative breast cancer with a CRL — not unexpected given its disastrous adcomm

5 years ago

Novartis and Genentech push for clarity from FDA on how disease progression models can be used for regulatory decisions

5 years ago

FDA can do more to ensure diversity in clinical trials, experts say — including some constructive badgering

5 years ago

Looking to lift clinical hold, uniQure contends its gene therapy was likely not the cause of single liver cancer case

5 years ago

FDA puts its foot down on Makena: New meta-analysis does not change call to pull the drug

5 years ago

House Dems call on the FTC to investigate potential collusion among top three insulin manufacturers

5 years ago

GlaxoSmithKline and Vir submit Covid-19 mAb for emergency authorization

5 years ago

EMA: Ongoing study data of Celltrion’s mAb enough to allow its use in some Covid-19 patients

5 years ago

FDA expert panel lines up 19-to-1 against Pfizer’s osteoarthritis drug tanezumab

5 years ago

US to no longer distribute Eli Lilly’s bamlanivimab alone due to coronavirus variants

5 years ago

HHS inspector general signs off on Novartis paying for pricey Kymriah

5 years ago

FDA adds Guillain-Barré syndrome warning to GlaxoSmithKline’s shingles vaccine

5 years ago

Teva sees room for growth with FDA communications and complex generics, COO says

5 years ago

Tougher regulatory environment for biopharma? Debate ensues

5 years ago

After spurning Sanofi for diabetes disappointment, Zealand nets FDA approval in severe hypoglycemia

5 years ago

‘A mess across the board’: Senate committee kicks off talks on drug pricing reforms

5 years ago

NIH panel letter accused AstraZeneca of embellishing the data for its Covid-19 vaccine — report

5 years ago

FDA's No. 2 Amy Abernethy to leave the agency in April

5 years ago

With at least one gastric cancer approval on the line, Merck's Keytruda scores nod for early patients in chemo combo

5 years ago

Novo Nordisk slammed with an RTF as the FDA raises CMC issues

5 years ago

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