NEWS

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Shots: The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & Australia sNDA was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM)…

August 11, 2025

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

Shots: The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated Approval was based on the DREAM trial, which met its 1 & 2EPs, showing a 63.5% AHI responder rate, 71.3% oxygen desaturation index responder rate, & 70.8% median AHI…

August 11, 2025

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

Shots: Novartis has reported topline P-III (NEPTUNUS-1 & 2) trial data assessing ianalumab (VAY736) in adults with active Sjögren's disease NEPTUNUS-1 assessed ianalumab (300mg, QM) vs PBO in 275 Sjögren's disease pts for 52wks. while NEPTUNUS-2 evaluated ianalumab (300mg; QM or Q3M) vs PBO for up to 52wks. in 504 pts; pts could then either…

August 11, 2025

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

August 11, 2025

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots: The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

August 8, 2025

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

August 8, 2025

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Shots: A management-led syndicate, supported by global investors, will acquire a majority stake in HistoSonics for $2.25B The acquisition was led by K5 Global, Bezos Expeditions, Wellington Management, Alpha JWC Ventures, Venture Investors Health Fund, Lumira Ventures, & over 10 other private & public investors HistoSonics aims to expand its Edison histotripsy system beyond liver tumors…

August 8, 2025

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25 In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing…

August 8, 2025

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Shots: XtalPi has entered into a strategic collaboration with DoveTree Medicines to identify novel therapeutics across oncology, immunology, inflammation, neurology, & metabolic diseases, leveraging XtalPi's de novo drug discovery platform As per the deal, DoveTree will gain exclusive global rights to develop & commercialize multiple therapeutics from the collaboration, in exchange for a $51M upfront,…

August 8, 2025

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Shots: The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025 In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…

August 8, 2025

NEWS

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

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