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 a first-line therapy for adults with advanced ... Read More
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 disease (GVHD) in patients who have not ... Read More
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 test as a primary screening option for ... Read More
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 the U.S. Food and Drug Administration (FDA) ... Read More
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 a standalone treatment for adults with treatment-resistant ... Read More
Huge relief for GERD patients: Phathom Pharmaceuticals wins FDA nod for VOQUEZNA
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a pioneering biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for VOQUEZNA 10 mg tablets, designed to ... Read More
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 U.S. Food and Drug Administration (FDA) approval ... Read More
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 mg/mL, a cutting-edge treatment for wet, or ... Read More
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 eye care with the U.S. Food and ... Read More
Johnson & Johnson’s TB drug SIRTURO receives full approval from FDA and EC
In a significant development for the treatment of drug-resistant tuberculosis (TB), Johnson & Johnson has announced that SIRTURO (bedaquiline) has received full approval from the ... Read More