Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%) Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…

ByRidhi Rastogi12 hours ago

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Altimmune Reports the P-IIb (IMPACT) Trial Data on Pemvidutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: Altimmune has reported 48wk. data from the P-IIb (IMPACT) trial assessing pemvidutide (1.2 or 1.8mg, SC, QW) vs PBO in 212 pts with MASH & fibrosis stages F2 or F3, with & without diabetes Pemvidutide (1.8mg) showed a reduction in triglycerides by 23.7%, total cholesterol by 15.4%, BMI by 3kg/m², waist circumference by 5.3cm,…

ByRidhi Rastogi13 hours ago

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Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026) NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…

ByRidhi Rastogi15 hours ago

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Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

Shots: Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…

ByRidhi Rastogi16 hours ago

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AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…

ByRidhi Rastogi17 hours ago

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Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Shots: Innovent will advance the early-stage & de novo cancer therapies, incl. ADCs through P-I before Pfizer assumes global development, with Pfizer securing exclusive global rights to 4 programs & will be responsible for the global development costs Also, Pfizer will obtain exclusive ex-Greater China rights to 4 additional programs & fund the majority of development…

ByRidhi Rastogi18 hours ago

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Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…

ByRidhi Rastogi2 days ago

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Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

Shots: Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO At Wk. 16, mid-dose also met key 2EP…

ByRidhi Rastogi2 days ago

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GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Shots: GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220…

ByRidhi Rastogi2 days ago

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Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

Shots: The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms The Software integrates its CardioTag wearable sensor with AI to…

ByRidhi Rastogi2 days ago

Ridhi Rastogi

Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Altimmune Reports the P-IIb (IMPACT) Trial Data on Pemvidutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

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