The US FDA New Drug Approvals in November 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024 The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…

ByDipanshu DixitDecember 10, 2024

NEWS

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

Shots: The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to…

ByDipanshu DixitDecember 4, 2024

NEWS

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Shots: Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…

ByDipanshu DixitAugust 14, 2024

NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

Shots: The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…

ByDipanshu DixitJune 10, 2024

NEWS

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

Shots: The US FDA has granted accelerated approval to Ojemda for treating r/r pLGG patients (≥6mos.) with BRAF fusion/rearrangement or BRAF V600 mutation. It further obtained FDA’s rare pediatric disease priority review voucher The approval was based on the P-II (FIREFLY-1) study assessing the efficacy (arm 1, n=77) & safety (arm 2, n=60) of Ojemda.…

ByDipanshu DixitApril 23, 2024

The US FDA New Drug Approvals in November 2024

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

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