Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug…
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. The…
Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based chemotherapy…
First and only rescue medication approved in the US for as-needed use to reduce risk of asthma exacerbations Airsupra (albuterol/budesonide), formerly known as PT027, has…
Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category…
FDA accepts nirsevimab application as first protective option against RSV disease for all infants The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation…
PT027 recommended by FDA Advisory Committee as new deliverance treatment for asthma First and only deliverance drug recommended for US blessing that has been shown…
Mirena ® approved in Europe for extended duration of use in contraception Mirena ®( 52 mg LNG IUS), Bayer’s long- acting reversible intrauterine system, entered…
TheU.S. Food and Drug Administration moment approved Relyvrio( sodium phenylbutyrate/ taurursodiol) to treat cases with amyotrophic side sclerosis( ALS), generally appertained to as Lou Gehrig’s…
Dupixent ®( dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularisDupixent significantly reduced itch and skin lesions compared to placebo…
Koselugo approved in Japan for paediatric cases with plexiform neurofibromas in neurofibromatosis type 1 First drug approved in Japan to treat this rare and enervating…
First and only long-acting C5 inhibitor has demonstrated early onset and sustained clinical benefit, and may reduce treatment burden with dosing every 8 weeks Improvement…