Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi Rastogi1 hour ago

NEWS

Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients

Shots: The EC has approved Lojuxta (lomitapide capsules) for the treatment of children (≥5yrs.) with Homozygous Familial Hypercholesterolaemia (HoFH), alongside diet & other lipid-lowering treatments, incl. LDL-apheresis Approval was based on the P-III (APH-19) trial evaluating Lojuxta in 43 pediatric pts (5 to 17yrs.) with HoFH Trial met its 1EP, showing a mean 53.5% reduction…

ByRidhi Rastogi4 days ago

NEWS

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

Shots: Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…

ByRidhi Rastogi5 days ago

NEWS

AbbVie’s Aquipta Receives EC Approval for Acute Migraine Treatment

Shots: The EC has approved AbbVie's Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed Approval was supported by the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (60mg, PO) vs PBO as an acute treatment of migraine with or without aura in 1,328 adults (18-75yrs.) Trial met…

ByRidhi RastogiJune 2, 2026

NEWS

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

Shots: The EC has approved Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after 1L treatment with Pt-based CT Approval was based on the P-III (DeLLphi-304) trial assessing Imdelltra vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the…

ByRidhi RastogiJune 2, 2026

NEWS

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 RastogiMay 29, 2026

NEWS

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 RastogiMay 29, 2026

NEWS

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis

Shots: The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated Zaynich is an injectable…

ByDipanshu DixitMay 29, 2026

NEWS

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 RastogiMay 28, 2026

NEWS

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

AbbVie’s Aquipta Receives EC Approval for Acute Migraine Treatment

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

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

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

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis

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

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Contact US

FOLLOW US