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Hanmi Pharm Inks ~$1.26B Deal with Eli Lilly to Advance Sonefpeglutide
Shots: Hanmi Pharm has granted Eli Lilly exclusive global rights (excl. Korea) to develop, manufacture & commercialize sonefpeglutide, a GLP-2 analog incorporating Hanmi's long-acting platform tech, Lapscovery As per the deal, Hanmi will receive $75M upfront & up to $1.185B in clinical development, regulatory approval, and commercialization milestone payments, with royalties following product launch Hanmi…
June 1, 2026
Merck
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…
May 29, 2026
Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention
Shots:  The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19  Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on…
May 29, 2026
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…
May 29, 2026
Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery 
Shots:  The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery  Cipepofol (Chinese trade name: Sishuning) is China's first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation  In Dec 2020, Cipepofol, approved…
May 29, 2026
Samsung Bioepis
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…
May 29, 2026
Astrazeneca
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…
May 29, 2026
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