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The European Commission has granted marketing authorization for the intravenous ( IV ) formulation of Entyvio ( Vedolizumab ) for the treatment of adult patients with moderately to severely active chr ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Vijoice ( Alpelisib ) for the treatment of adult and pediatric patients 2 years of age and older with severe manifesta ...


The European Commission ( EC ) has approved Opdivo ( Nivolumab ) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression 1% or more who are at a ...


The Committee for Medicinal Products for Human Use ( CHMP ), the scientific Committee of the European Medicines Agency ( EMA ), adopted a positive opinion for the use of Quviviq ( Daridorexant ) as th ...


The European Commission has granted marketing authorization in the European Union ( EU ) for Finerenone under the brand name Kerendia. Kerendia ( 10 mg or 20 mg ), a non-steroidal, selective mineral ...


The U.S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ) 360 mg ( injection for intravenous use ) in combination with Platinum-doublet chemotherapy every three weeks for three c ...


The European Commission ( EC ) has granted marketing authorization for Jardiance ( Empagliflozin ), an oral, once-daily, highly selective sodium-glucose cotransporter 2 ( SGLT2 ), as a treatment for a ...


The European Commission ( EC ) has granted conditional marketing authorization for Lumykras ( Sotorasib ), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell ...


The U.S. Food and Drug Administration ( FDA ) has approved Cosela ( Trilaciclib ) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults re ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Tivdak ( Tisotumab vedotin-tftv; Tisotumab vedotin ), the first approved antibody-drug conjugate ( ADC ) for the treat ...


Adbry ( Tralokinumab-ldrm; Tralokinumab ) is a biologic drug approved by the FDA ( Food and Drug Administration ) for adults ( 18+ years ) with moderate to severe atopic dermatitis whose disease is no ...


The Food and Drug Administration ( FDA ) has approved Welireg ( Belzutifan ), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau ( VHL ) disease who require therapy for ass ...


The U.S. Food and Drug Administration ( FDA ) has approved Exkivity ( Mobocertinib ) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with e ...


FDA has approved Kerendia ( Finerenone ) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart fai ...


Imcivree is a medicine used to treat obesity and help control hunger caused by certain genetic conditions that affect how the brain controls feelings of hunger. It is used in adults and children aged ...


The US Food and Drug Administration ( FDA ) has approved Nucala ( Mepolizumab ), a monoclonal antibody that targets interleukin-5 ( IL-5 ), as a treatment for patients with chronic rhinosinusitis with ...


The U.S. Food and Drug Administration ( FDA ) has approved Vyvgart ( Efgartigimod ) for the treatment of generalized myasthenia gravis ( gMG ) in adults who test positive for the anti-acetylcholine re ...


The FDA ( U.S. Food and Drug Administration ) has granted the accelerated approval of Rybrevant ( Amivantamab-vmjw; Amivantamab ) for the treatment of adult patients with locally advanced or metastati ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Truseltiq ( Infigratinib ), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metasta ...


The U.S. Food and Drug Administration ( FDA ) has approved the expansion of the Kyprolis ( Carfilzomib ) prescribing information to include its use in combination with Darzalex Faspro ( Daratumumab an ...


FDA ( Food and Drug Administration ) has approved Leqvio ( Inclisiran ) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial ...


The U.S. Food and Drug Administration ( FDA ) has issued an emergency use authorization ( EUA ) for Pfizer’s Paxlovid ( Nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use ) for the t ...


The FDA ( Food and Drug Administration ) has approved Tecartus ( Brexucabtagene autoleucel ) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ( ALL ). Ef ...


The European Commission has approved Adtralza ( Tralokinumab ) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. Tralokinumab is a ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Scemblix ( Asciminib ) for patients with Philadelphia chromosome-positive chronic myeloid leukemia ( Ph+ CML ) in chronic p ...


The European Commission ( EC ) has approved Rinvoq ( Upadacitinib ), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescent ...


The U.S. Food and Drug Administration ( FDA ) ha approved Opdivo ( Nivolumab ) 240 mg every two weeks or 480 mg every four weeks ( injection for intravenous use ) for the adjuvant treatment of patient ...


The European Commission ( EC ) has approved Ponvory ( Ponesimod ) for the treatment of adult patients with relapsing multiple sclerosis ( RMS ) with active disease defined by clinical or imaging featu ...


The U.S. Food and Drug Administration ( FDA ) has approved the combination of Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, plus Lenvima ( Lenvatinib ), the orally available multiple receptor tyro ...


The FDA ( U.S. Food and Drug Administration ) has approved Kerendia ( Finerenone ), the first non-steroidal, selective mineralocorticoid receptor ( MR ) antagonist. Finerenone 10 mg or 20 mg is indic ...


The U.S. Food and Drug Administration, FDA, has approved Aduhelm ( Aducanumab ) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using ...


The U.S. Food and Drug Administration ( FDA ) has approved Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ) for the treatment of adult patients with relapsed or refractory ( r/r ) larg ...


The U.S. Food and Drug Administration ( FDA ) has approved Pradaxa ( Dabigatran etexilate ) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism directly after ...


The U.S. Food and Drug Administration ( FDA ) has approved Lumakras ( Sotorasib ) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic ...


Tagrisso ( Osimertinib ), an irreversible epidermal growth factor receptor tyrosine kinase inhibitor ( EGFR TKI ), has been approved in the European Union ( EU ) for the adjuvant treatment of adult pa ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ), a CD19-directed antibody and alkylating agent conjugate, ...


The European Commission ( EC ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ) for the treatment of adult patients with relapsed multiple myeloma who have ...


Farxiga ( Dapagliflozin ), a sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate ( eGFR ) decline, end- ...


European Commission has approved Tecentriq ( Atezolizumab ) as a first-line treatment for adults with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have high PD-L1 expression, with no ...


The FDA ( US Food and Drug Administration ) has approved Jemperli ( Dostarlimab-gxly; Dostarlimab ), a programmed death receptor-1 ( PD-1 ) blocking antibody. Dostarlimab is indicated for the treatmen ...


The FDA ( Food and Drug Administration ) has approved Enhertu ( fam-Trastuzumab Deruxtecan-nxki; fam-Trastuzumab Deruxtecan ) for adult patients with locally advanced or metastatic HER2-positive gastr ...


The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval of Trodelvy ( Sacituzumab govitecan-hziy; Sacituzumab govitecan ) for use in adult patients with locally advanced or meta ...


The FDA ( U.S. Food and Drug Administration ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ), for the treatment of adult patients with relapsed or refrac ...


The FDA ( U.S. Food and Drug Administration ) has approved supplemental New Drug Application ( sNDA ) for Lorbrena ( Lorlatinib ), a tyrosine kinase inhibitor ( TKI ), expanding the indication to incl ...


The U.S. Food and Drug Administration ( FDA ) has approved Ponvory ( Ponesimod ), a once-daily oral selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator, to treat adults with relapsing form ...


The FDA ( U.S. Food and Drug Administration ) has approved Darzalex Faspro ( Daratumumab and Hyaluronidase-fihj ), a subcutaneous formulation of Daratumumab, in combination with Bortezomib, Cyclophos ...


The FDA ( U.S. Food and Drug Administration ) has approved the PD-1 inhibitor Libtayo ( Cemiplimab-rwlc; Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ...


The European Commission ( EC ) has granted marketing authorization for Tukysa ( Tucatinib ) in combination with Trastuzumab and Capecitabine for the treatment of adult patients with HER2-positive loca ...


The FDA ( US Food and Drug Administration ) has approved the following expanded indication for Entresto ( Sacubitril / Valsartan ): to reduce the risk of cardiovascular death and hospitalization for h ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Ukoniq ( Umbralisib ), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications ...