Browsing Tag
FDA approval
131 posts
Renalytix plc terminates formal sale process amid strategic realignment and market reaction
Renalytix plc, a prominent player in artificial intelligence-enabled in vitro diagnostics, has officially terminated its Formal Sale Process,…
FDA approves RYBREVANT and LAZCLUZE for EGFR-mutated advanced lung cancer
The U.S. Food and Drug Administration (FDA) has approved the combination of RYBREVANT (amivantamab-vmjw) and LAZCLUZE (lazertinib) as…
Niktimvo FDA approval brings new hope for chronic graft-versus-host disease patients
The U.S. Food and Drug Administration (FDA) has approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host…
FDA gives green light to Guardant Health’s Shield blood test: A game-changer in colorectal cancer screening and Medicare coverage
In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Guardant Health, Inc.’s Shield blood…
Sun Pharmaceutical bags LEQSELVI FDA approval for severe alopecia areata
In a significant development for the treatment of severe alopecia areata, Sun Pharmaceutical Industries Limited has announced that…
Johnson & Johnson seeks FDA approval for SPRAVATO in treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) is seeking U.S. Food and Drug Administration (FDA) approval for SPRAVATO (esketamine) as…
Phathom Pharmaceuticals secures FDA approval for VOQUEZNA to treat non-erosive GERD in adults
FDA approves Phathom’s VOQUEZNA for Non-Erosive GERD, offering the first new acid suppression class in decades for millions of U.S. adults.
FDA approves Arcutis Biotherapeutics’ ZORYVE for pediatric and adult atopic dermatitis
In a significant development for the treatment of atopic dermatitis (AD), Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the…
Genentech announces reintroduction of Susvimo for Wet AMD treatment in US
Genentech, a key member of the Roche Group, has officially announced the reintroduction of Susvimo (ranibizumab injection) 100…
FDA approves Roche’s Vabysmo prefilled syringe for eye diseases, expanding treatment options for millions
Roche (SIX: RO, ROG; OTCQX: RHHBY), a global leader in pharmaceuticals and diagnostics, announced a significant advancement in…