Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Shots: The UK’s MHRA has approved Oczyesa (octreotide SC depot) for the maintenance treatment in adult with acromegaly who have responded to & tolerated somatostatin analogs, following EC approval on Jun 30, 2025; UK launch expected in Q4’25 Approval was based on extensive data from 7 trials, incl. 4 P-I trials, 1 P-II trials &…

ByRidhi RastogiAugust 29, 2025

NEWS

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Shots: Health Canada has approved Rinvoq (15mg; QD) as a monotx. & in combination with corticosteroid to treat adults with giant cell arteritis (GCA) Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…

ByRidhi RastogiAugust 28, 2025

NEWS

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Shots: FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…

ByRidhi RastogiAugust 28, 2025

NEWS

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJM Approval is…

ByRidhi RastogiAugust 27, 2025

NEWS

Abbott Reports the Approval for its Denosumab Biosimilar in Thailand

Shots: Abbott has secured regulatory approval for its denosumab biosimilar in Thailand, increasing access to advanced treatments for osteoporosis and cancer-related bone loss Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation Abbott will offer denosumab as part of its strategy to expand access to quality medicines in…

ByDipanshu DixitAugust 26, 2025

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Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Shots: China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer Study showed improved PFS by 37%…

ByRidhi RastogiAugust 25, 2025

NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…

ByRidhi RastogiAugust 25, 2025

NEWS

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) &…

ByRidhi RastogiAugust 22, 2025

NEWS

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Shots: The EC has approved Mynzepli (AVT06), a biosimilar version of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs…

ByRidhi RastogiAugust 21, 2025

NEWS

Tonix Pharmaceuticals’ Tonmya Receives the US FDA’s Approval for Fibromyalgia

Shots: The US FDA has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults; commercially available in Q4’25 Approval was based on 2 P-III (RELIEF & RESILIENT) trial assessing Tonmya vs PBO in 503 & 457 pts, respectively in the US, where pts started on Tonmya 2.8mg & increased the dose…

ByRidhi RastogiAugust 19, 2025

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Abbott Reports the Approval for its Denosumab Biosimilar in Thailand

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Tonix Pharmaceuticals’ Tonmya Receives the US FDA’s Approval for Fibromyalgia

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