Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots:The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

ByRidhi Rastogi1 hour ago

NEWS

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots:The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings plannedApproval was based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…

ByRidhi Rastogi3 days ago

NEWS

GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

Shots:The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA under NMPA’s priority reviewApproval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single…

ByRidhi Rastogi3 days ago

NEWS

Taiho Pharmaceutical Secures Exclusive Licensing Rights for Casdatifan from Arcus Biosciences in Japan and Select Asian Territories

Shots:Taiho Pharmaceutical has exercised its option to develop & commercialize casdatifan, pending approval in Japan & other Asian regions (excl. Greater China) under Taiho & Arcus’ 2017 option & license agreementAs per the deal, Arcus will receive an option exercise payment & clinical, regulatory, plus commercial milestone payments, with net sales-based royalties. Although…

ByRidhi Rastogi5 days ago

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Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots:The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in ChinaOpinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…

ByDipanshu DixitOctober 22, 2025

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Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Shots:The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitorTrial met its 1EP of improved PFS by 38% (mPFS:…

ByRidhi RastogiOctober 22, 2025

NEWS

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots:The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…

ByDipanshu DixitOctober 21, 2025

NEWS

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Shots:The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible ptsApproval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…

ByRidhi RastogiOctober 21, 2025

NEWS

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiationOpinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat…

ByRidhi RastogiOctober 21, 2025

NEWS

Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPCsNDA was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

ByRidhi RastogiOctober 17, 2025

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

Taiho Pharmaceutical Secures Exclusive Licensing Rights for Casdatifan from Arcus Biosciences in Japan and Select Asian Territories

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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