Sanofi's third-generation antihistaminic Allegra Tab 120 mg (fexofenadine hydrochloride) has been suspended from advertising for two months.The Ministry of Food and Drug Safety issued a two-month advertising suspension for Allegra Tab on June 23. The suspension period is from June 27 to Aug. 26.Hand
In a shocking revelation, it has come to light that Minoxidil Tab. Hyundai, the company's hypertension treatment which is more famous for its off-label use as a hair loss treatment, has inadvertently been labeled as Tamirin ER Tab., a dementia treatment, and given to dementia patients.The impact of
SK biopharmaceuticals has decided to acquire Proteovant Sciences, a joint venture established in the U.S.The company said in a public filing Friday that it would acquire 40 million shares of Proteovant valued at about 62 billion won ($47.5 million). SK biopharmaceuticals will acquire the shares with
The Ministry of Food and Drug Safety (MFDS) has approved an expanded indication for Yuhan Corp.'s Leclaza (ingredient: lazertinib), an epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treatment, to be used as first-line treatment.Leclaza is the 31st new dr
AstraZeneca said it would introduce a highly concentrated formulation of Ultomiris (ravulizumab), which maintains the efficacy of the original formulation while reducing infusion time, in the Korean market. AstraZeneca Korea announced that it will launch high-concentration formulations (300mg/3mL an
Novartis' Scemblix (asciminib) will receive reimbursement for the third-line or more treatment of chronic myeloid leukemia patients in Korea starting next month.The Health Insurance Review and Assessment Service (HIRA) said Thursday that it has revised and published details on the criteria and metho
SK bioscience said on Friday that it confirmed the excellent immunogenicity and safety of its 21-valent pneumococcal protein conjugate vaccine, GBP410, in phase 2 clinical trials in infants.Based on this data, SK bioscience and Sanofi plan to initiate a phase 3 study in the first half of 2024, expec
SK plasma's contract to supply blood products to Singapore was dramatically reduced in size in a day.The mishap, which the company attributed to a misinformed down payment unit and contract period, will likely deal a blow to the corporate image, industry watchers said.SK plasma, an affiliate of the
Eli Lilly’s Mounjaro (tirzepatide), the so-called dream drug to treat diabetes and obesity, drawing global attention, has won approval from the Ministry of Food and Drug Safety.However, due to the rapid increase in demand in developed markets, including the U.S., it is unclear whether there is enoug
Boryung said it launched Korea's first alcohol-free docetaxel liquid anticancer drug, Ditaxel Inj., for the treatment of breast cancer.First launched in 2012, Ditaxel is a taxane-based anticancer drug used to treat breast cancer and has a wide range of indications, including non-small cell lung canc
EuBiologics said it has voluntarily withdrawn its application for a domestic item license for Eubitox 100 units, its botulinum toxin (BTX) treatment because it missed the timing for supplementary data submission to the regulator.The company applied to the Ministry of Food and Drug Safety for approva
Daewoong Pharmaceutical is again under investigation by prosecutors over allegations that it stole Medytox's botulinum toxin (BTX) strain technology, Maeil Business Newspaper first reported on Wednesday.According to the report, the Seoul High Prosecutors' Office's Criminal Division ordered the Seoul
Celltrion Healthcare has set about to dispel concerns over the poor sales outlook of its Humira biosimilar, Yuflyma (adalimumab), even before it debuted in the U.S. market.According to industry sources, Celltrion Healthcare's recent failure to put Yuflyma on the Humira biosimilar prescription drug l
AbbVie Korea is strengthening its position in the local botulinum toxin (BTX) market with Botox armed with long-term safety and clinical data.AbbVie Korea held a press conference at the Plaza Hotel on Wednesday in Seoul to celebrate the launch of Botox under AbbVie after the company completed the me
MSD Korea has applied to consider expanding insurance coverage criteria for 13 indications of its anti-PD-1 immunotherapy Keytruda (pembrolizumab), including endometrial and cervical cancer.The 13 indications are early-stage triple-negative breast cancer; metastatic or recurrent triple-negative brea
HanAll Biopharma said it would receive a milestone payment from Roivant Sciences, a Switzerland-based company, for the technology transfer regarding an investigational autoimmune disease treatment HL161 (ingredient: batoclimab).In a regulatory filing on Wednesday, HanAll said it was scheduled to rec
The Ministry of Food and Drug Safety (MFDS) has dismissed R Bio's appeal regarding the approval denial for Nature Cell's stem cell therapy, JointStem, to treat severe osteoarthritis.R Bio is the largest shareholder of Nature Cell and the original developer of JointStem.According to Vision Korea, a s
Daewoong Pharmaceutical said it has submitted a new drug application for Fexuclue 40mg (ingredient: fexuprazan), a potassium-competitive acid blocker (P-CAB) developed in-house, to the Center for Drug Evaluation under the National Medical Products Administration (NMPA) of China.The P-CAB class of dr
Icure Pharmaceutical's good manufacturing practice (GMP) violations have led to widespread administrative penalties.According to the Ministry of Food and Drug Safety, Chong Kun Dang and Dongkook Pharmaceutical's pain-relieving patch Kefem Plaster and Sarafen Plaster received a three-month administra
JW Pharmaceutical is drawing attention by reapplying for the global phase 3 clinical trial of its gout treatment candidate, epaminurad (URC102).The company said in a public filing Monday that it has submitted the renewed application to the Taiwan Food and Drug Administration (TFDA).JW Pharmaceutical