The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The EC has approved Dawnzera (SC autoinjector; Q4W/Q8W) for the routine prevention of HAE attacks in pts (≥12yrs.) Approval was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly reduction at 1yr. in the OASISplus OLE study Approval…

ByRidhi Rastogi5 days ago

INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2025

Shots: Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks In…

ByDipanshu DixitDecember 16, 2025

NEWS

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

ByRidhi RastogiNovember 26, 2025

NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…

ByRidhi RastogiNovember 17, 2025

NEWS

4D Molecular Therapeutics Collaborates with Otsuka Pharmaceutical to Develop and Commercialize 4D-150 in the APAC Region

Shots: 4DMT has granted Otsuka exclusive rights to develop & commercialize 4D-150 for retinal vascular diseases, incl. wet age-related macular degeneration (wet AMD) & diabetic macular edema (DME) in Japan, China, Australia & other APAC markets, while retaining rights in other regions As per the deal, Otsuka will lead all regulatory & commercialization efforts in…

ByRidhi RastogiOctober 31, 2025

TOP 20

Top 20 Nutraceutical Companies of 2025

Shots: Nutraceuticals offer significant health benefits by enhancing body function and supporting body repair and growth In 2024, the global nutraceuticals market is valued at $458.55B and is projected to rise to $986.85B by 2032, growing at a CAGR of 10.18%. Nestlé leads the market with reported segment revenue of $16.75B, followed by Danone and…

ByPrince GiriJune 19, 2025

NEWS

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots: The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in May 2023

Shots: The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023 In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease PharmaShots has…

BySenior EditorJune 21, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2023

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots: Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS The interview gives an understanding of how Aurinia…

BySenior EditorDecember 7, 2022

The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

EMA Marketing Authorization of New Drugs in November 2025

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Top 20 Nutraceutical Companies of 2025

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Insights+: The US FDA New Drug Approvals in May 2023

Insights+: The US FDA New Drug Approvals in April 2023

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

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