BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots:The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapyApproval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC ptsTrial…

ByRidhi RastogiJuly 10, 2025

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AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots:The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regionsApproval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi RastogiJuly 4, 2025

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Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Shots: The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New ZealandIn 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…

ByRidhi RastogiJuly 2, 2025

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Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots:The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapyApproval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…

ByRidhi RastogiJuly 2, 2025

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PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Shots:The EC has approved Sephience (sepiapterin) to treat PKU in pts of all ages and disease severities across all 30 EEA states; launch is anticipated in Germany in H1 of JulyApproval was based on APHENITY study results and long-term extension data showing durable effects and improved dietary flexibilitySephience is an oral synthetic…

ByDipanshu DixitJune 24, 2025

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Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots:The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA statesThe EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…

ByDipanshu DixitJune 23, 2025

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Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Shots:The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. to advanced liver fibrosis; the EC’s decision is expected by Aug 2025Opinion was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which met its 1EPs of fibrosis improvement…

ByRidhi RastogiJune 23, 2025

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Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Shots:The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRPApproval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD ptsAveroa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

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Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots:The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM ptsThe study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk…

ByDipanshu DixitJune 10, 2025

News

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Shots:The EC has granted conditional approval to Duvyzat (givinostat) for the treatment of ambulant DMD pts (≥6yrs.) on corticosteroids, regardless of underlying genetic mutation in all 30 EEA statesApproval was based on the P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant DMD boys (n=179) on corticosteroid therapyTrial met its 1EP…

ByRidhi RastogiJune 9, 2025

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

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