Business Insider3 天
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for ...
(Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI ...
pharmaphorum3 天
When measuring European regulatory approval, the timestamp matters
In the U.S., FDA cycle times are calculated from the time a drug is submitted for approval to when it is granted approval. Almost immediately after the FDA grants approval, the drug is authorized ...
thecardiologyadvisor.com4 天
FDA Drug Approval Decisions Expected in March 2025
The FDA reviews drug approval decisions that are expected in March 2025. The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled ...
pharmaphorum3 天
EMA’s strategy for speeding up drug approvals in the EU
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
The Pharma Letter3 天
FDA approves Evrysdi as first and only tablet for SMA
The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) from Swiss pharma giant Roche’s (ROG: SIX) Genentech subsidiary for an Evrysdi (risdiplam) tablet for people living ...
The Pharma Letter3 天
New FDA approval for Pfizer’s Adcetris
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer (NYSE: ...
asco.org5 天
Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines ...
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