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NEWS

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots: Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative options Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
3 days ago

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NEWS

Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

Shots: The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25 Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
3 days ago

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NEWS

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots: Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint Calibreye System allows ophthalmologists to control…
August 13, 2025

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NEWS

PBI-Gordon Companies Reports US Availability of Felycin-CA1 to Treat Feline Hypertrophic Cardiomyopathy

Shots: PBI-Gordon Companies has reported US availability of Felycin-CA1 (sirolimus delayed-release tablets) via licensed veterinarians Felycin-CA1 has been conditionally approved by the US FDA for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM) based on RAPACAT study The company is seeking a full new animal drug approval of Felycin-CA1 for cats with HCM through the…
July 31, 2025

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NEWS

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 therapy Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…
July 2, 2025

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Sarepta Therapeutics
NEWS

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Shots: Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 Abs Approval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
May 14, 2025

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Carmat
NEWS

The US FDA Grants Conditional Approval to Initiate Second Cohort of the EFS Study of CARMAT’s Aeson Artificial Heart

Shots: The US FDA has granted conditional approval to initiate the second cohort of the early feasibility study (EFS) of the Aeson artificial heart in the US by H2’25, pending ethics committee approval & personnel training; launch expected by 2028 EFS is being conducted in 2 cohorts; first (n=3) was completed in Q3’21, leading to FDA-approved…
April 15, 2025

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