Namasthe

South Korea’s HIRA to Advise Drugmakers on Faster Rare Disease Listings South Korea’s Health Insurance Review and Assessment Service is preparing a consultation meeting for pharmaceutical companies as part of a pilot program intended to speed up insurance coverage for rare disease treatments. The meeting is designed to help companies understand how the accelerated listing pathway works and how they can apply for coverage for individual products. HIRA and NHIS Join Effort Seve

The Saudi Food and Drug Authority has become the first regulatory agency worldwide to approve iberdomide for adults with relapsed or refractory multiple myeloma. The treatment, marketed as ZENBEXUS, is authorized for use alongside daratumumab and dexamethasone in patients whose disease has returned or no longer responds adequately to earlier treatment. The SFDA announced the decision on August 11, 2026. Approval Based on Phase 3 Evidence The registration was supported by resu

AstraZeneca Pharma India has secured regulatory clearance from the Central Drugs Standard Control Organisation (CDSCO) to introduce a new first-line therapeutic option for adults facing unresectable or metastatic HER2-positive breast cancer. The approved regimen pairs trastuzumab deruxtecan with pertuzumab. Given the aggressive nature of HER2-positive breast cancer, which stems from HER2 gene amplification and impacts a significant portion of Indian patients, this approval ad

Saudi Food and Drug Authority (SFDA) has approved the registration of Anktiva (nogapendekin alfa inbakicept) for selected bladder and lung cancer indications, introducing a new immunotherapy option for patients with limited treatment choices. Under the new authorization, Anktiva may be used for adult patients with metastatic non‑small cell lung cancer whose disease has progressed after standard systemic therapies, in combination with immune checkpoint inhibitors. SFDA has als

HUTCHMED and Innovent Biologics have announced that the China National Medical Products Administration (NMPA) has conditionally approved...

HUTCHMED has announced that the China National Healthcare Security Administration (NHSA) has renewed the inclusion of savolitinib in the...

The 2024 National Reimbursement Drug List (NRDL) unveiled by China's National Healthcare Security Administration adds 91 new drugs,...

Eisai and Biogen have announced that the United Arab Emirates (UAE) Ministry of Health and Prevention has granted approval for Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, for the treatment of Alzheimer's disease (AD). Leqembi is recommended for patients in the early stages of AD, specifically those with mild cognitive impairment (MCI) or mild dementia, as was the case in the clinical trials. Leqembi targets and binds to both

Biogen and Eisai have announced that the Department of Health in Hong Kong has approved Leqembi (lecanemab) for the treatment of...

Brazil and Thailand have become the first malaria-endemic nations to launch tafenoquine, a new single-dose medication aimed at preventing...

LEQEMBI (Lecanemab) Gains Approval in South Korea for Alzheimer’s Disease Treatment EiSai and Biogen have announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved the use of the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, LEQEMBI (lecanemab), for adult patients experiencing mild cognitive impairment due to Alzheimer’s disease (AD) or those in the early stages of the disease. LEQEMBI targets soluble Aβ aggregates (protofibr

AstraZeneca Granted CDSCO Authorization for Andexanet Alfa: Antidote for Severe Bleeding Tied to FXa Inhibitors AstraZeneca announced...

The Ministry of Health and Welfare (Minister: Cho Gyu-hong) has announced that starting from December 1, measures such as an increase in...

Eisai submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety (MFDS) to seek approval for lecanemab (known as Leqembi in the U.S.), an investigational anti-amyloid beta (Aβ) protofibril antibody. The application seeks approval for using lecanemab to treat early Alzheimer's disease, explicitly targeting mild cognitive impairment and mild dementia associated with Alzheimer's disease in individuals with confirmed amyloid pathology in the

India started vaccination of adolescents; Bharat Biotech says Covaxin demonstrated robust efficacy and safety in people of age 2-18 years...

China has released the 2021 Drug catalog, which included 2,860 drugs, out of which 1,486 drugs are Western drugs. Reuters reported a...

WHO has announced that it has granted emergency use listing for Covaxin developed by Bharat Biotech. This adds another vaccine to the...

Novartis entered a strategic collaboration with BeiGene to license tislelizumab; to market in major markets outside China, including...

Bayer has announced that it has submitted an application requesting the approval of vericiguat in China for the treatment of chronic...

Bayer has announced that the Chinese National Medical Products Administration (NMPA) approved Xofigo (radium-223 dichloride) for treating...

Merck has announced that it has received the approval of its anti-PD-1 therapy, Keytruda (pembrolizumab) for radically unresectable,...

The Japanese Ministry of Health, Labor, and Welfare approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with...

INTRODUCTION Japan has a population of 126 million, nearly twice the size of the UK population. Japan is the third-largest economy. The...

Gilead has announced that China’s National Medicinal Products Administration has approved Truvada (emtricitabine 200mg/tenofovir...

Approval of Dayvigo in Japan On July 6th, 2020, Eisai announced that it had launched Dayvigo (lemborexant) in Japan for insomnia. The...

Merck has announced that it has received approval from the Chinese National Medical Products Administration (NMPA) in China for Keytruda...

GSK has announced that Clover Biopharmaceuticals initiated the Phase 1 trial of COVID-19 vaccine SCB-2019. The vaccine was given in...

In Singapore, the Health Sciences Authority has approved three new products in May. Ajovy approved for migraine in adults Tuksya approved...

Gilead has announced top-line Phase 3 trial results of remdesivir in patients with COVID-19. The drug is indicated in moderate COVID-19...