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QIAGEN Launches QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing
Shots: QIAGEN has launched the CE-IVDR certified QIAstat-Dx BCID GPF Plus AMR Panel, marking its entry into syndromic testing for bloodstream infections  The panel identifies 20 gram-positive bacterial & fungal pathogen targets & 10 antimicrobial resistance markers, delivering results in ~1 hour to support rapid clinical decision-making & antimicrobial stewardship The panel was showcased at…
April 15, 2026
Merck new
Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 
Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…
April 15, 2026
Mochida Pharmaceutical Collaborates with Qilu Pharmaceutical to Develop & Commercialize of Follitropin Alfa (Biosimilar, Gonal‑f) Across Japan 
Shots:  Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan  As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market  Follitropin alfa is a recombinant FSH used for…
April 15, 2026
Mabwell  Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva) 
Shots:  The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors  Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may…
April 15, 2026
Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Shots: The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…
April 15, 2026
Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…
April 15, 2026
Eli Lilly to Acquire CrossBridge Bio for ~$300M
Shots: Eli Lilly has entered into a definitive agreement to acquire CrossBridge Bio, incl. its synergistic dual payload platform for the development of differentiated therapeutics As per the deal, Lilly will acquire CrossBridge Bio for ~$300M in cash, incl. an upfront payment & a subsequent milestone payment CrossBridge Bio is advancing CBB-120, a TROP2-targeting TOP1i/ATRi…
April 15, 2026
American Industrial Partners to Acquire Avanos Medical for ~$1.272B
Shots: Avanos Medical has entered into a definitive agreement to be acquired by affiliates of American Industrial Partners in an all-cash transaction valued at ~$1.272B enterprise value As per the deal, Avanos Medical shareholders will receive $25/share in cash, reflecting a ~72.1% premium to the Company's closing stock price on Apr 13, 2026; closing is…
April 14, 2026
Protaryx Medical Secures FDA Clearance for its Transseptal Access Device
Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization  The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026
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