This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below:
Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients
Read More: Memo therapeutics
Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL
Read More: Eli Lilly
AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata
Read More: AbbVie
IMUNON Reports First Patient Dosing in P-III (OVATION 3) Trial of IMNN-001 for Ovarian Cancer
Read More: IMUNON
Ultragenyx Completes Patient Enrolment in P-III (Aspire) Trial of GTX-102 for Angelman Syndrome
Read More: Ultragenyx
Vir Biotechnology Reports First Patient Enrolment in P-III (ECLIPSE 2) Trial of Tobevibart + Elebsiran for Chronic Hepatitis Delta (CHD)
Read More: Vir Biotechnology
KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema
Read More: KalVista
Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk
Read More: Gilead
Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression
Read More: Biogen
Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia
Read More: Sobi
Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome
Read More: Ionis
PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria
Read More: PTC Therapeutics
Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Read More: Deciphera Pharmaceuticals
Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN
Read More: Apellis Pharmaceuticals
IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)
Read More: IntraBio
AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia
Read More: AbbVie
LENZ Therapeutics’ Vizz Receives the US FDA’s Approval to Treat Presbyopia
Read More: LENZ Therapeutics
Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors
Read More: Novo Nordisk
BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia
Read More: BeOne Medicines
GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications
Read More: GSK and Hengrui Pharma
BI Collaborates with Re-Vana Therapeutics to Develop Long-Acting Therapeutics for Eye Diseases
Read More: BI and Re-Vana Therapeutics
Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies
Read More: BMS and Bain Capital
Viridian Therapeutics Enters a ~$385M Deal with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan
Read More: Viridian Therapeutics and Kissei Pharmaceutical
Madrigal Pharmaceuticals Signs a ~$2.1B Licensing Deal with CSPC Pharmaceutical for SYH2086
Read More: Madrigal Pharmaceuticals and CSPC Pharmaceutical
Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment
Read More: Cardiosense
SetPoint Medical Receives the US FDA’s Approval for its SetPoint System to Treat Rheumatoid Arthritis
Read More: SetPoint Medical
Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management
Read More: Bioventus
Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)
Read More: Henlius
Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases
Read More: Alteogen
PBI-Gordon Companies Reports US Availability of Felycin-CA1 to Treat Feline Hypertrophic Cardiomyopathy
Read More: PBI-Gordon Companies
Related Post: PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)