FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA approves AstraZeneca’s asthma medication Fasenra to treat rare autoimmune condition

7 months ago

FDA cancels Applied Therapeutics adcomm, shares skyrocket 65%

7 months ago

Senators tell FDA that ‘greater action is needed’ to use manufacturing tech in US supply chains

7 months ago

Theratechnologies' HIV drug to face supply issues in 2025 over third-party facility shutdown

7 months ago

Novartis’ Kisqali snags FDA approval to reduce recurrence in patients with early forms of breast cancer

7 months ago

Conducting trials via routine clinical practice: FDA explains how in new draft guidance

7 months ago

European regulators fortify single-arm trial advice, but underscore preference for placebo-controlled designs

7 months ago

FDA tells oncology companies how to run multi-regional cancer trials with a US approval in mind

7 months ago

FDA approves Lilly's eczema drug Ebglyss for moderate-to-severe disease

7 months ago

Adcomm says Intercept's rare liver disease drug should not get full approval

7 months ago

FDA approves subcutaneous Ocrevus, broadening access to Roche and Genentech blockbuster

7 months ago

Corrected: Roche’s Tecentriq scores first US approval for subcutaneous PD-L1

7 months ago

FDA revisits new structure for drug review documents, aiming to better explain its decisions

7 months ago

Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA

7 months ago

FDA should embrace new ways of evaluating rare disease drugs, report argues

7 months ago

J&J expands Tremfya into IBD with new FDA approval

8 months ago

FDA criticizes AbbVie's 'misleading' ad with Serena Williams

8 months ago

FDA is poised to pull Ocaliva as adcomm documents question post-approval study results

8 months ago

FDA drafts new strategy to boost the use of advanced manufacturing tech

8 months ago

Sanofi, Regeneron to refile Dupixent for skin condition after new study win

8 months ago

Congress spars over whether the Biosecure Act is an overdue crackdown or a rushed witch hunt

8 months ago

FDA sends warning letter to Indian drugmaker after finding glass in injections

8 months ago

FDA advisors question whether Iterum's application for a UTI antibacterial is restrictive enough

8 months ago

CDER chief on inspection backlog: 2025 will be a 'crucial year'

8 months ago

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