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Zoetis
NEWS

Zoetis’ Dectomax-CA1 Injectable Receives the US FDA’s Conditional Approval to Prevent New World Screwworm Infestations in Cattle

Shots:The US FDA has granted conditional approval to Dectomax-CA1 Injectable for the prevention & treatment of infestations caused by the larvae of Cochliomyia hominivorax (New World Screwworm; myiasis)Dectomax-CA1 Injectable is approved for use in beef cattle, female dairy cattle (<20mos. of age), pregnant beef cows, newborn calves & bulls, plus it is indicated for the prevention…
October 1, 2025

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Boehringer Ingelheim
NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots:China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapyApproval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…
September 1, 2025

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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 optionsApproval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
August 20, 2025

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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 Q4’25Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
August 20, 2025

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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 glaucomaThe IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpointCalibreye 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 veterinariansFelycin-CA1 has been conditionally approved by the US FDA for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM) based on RAPACAT studyThe 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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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 AbsApproval 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 2028EFS 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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