The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
Spain’s largest drugmaker Almirall has filed a Marketing Authorization Application to the European Medicines Agency for the fixed combination of aclidinium bromide (LAMA) and formoterol fumarate (LABA - long-acting beta2 agonist) for the treatment of chronic obstructive pulmonary disease (COPD). 4 November 2013
Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa as first-line treatment to 70% of their non-small-cell lung cancer patients. 4 November 2013
The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL), making it the first to be approved as first-line therapy for this condition. 4 November 2013
US drug major Bristol-Myers Squibb has filed a New Drug Application with Japan’s Pharmaceutical and Medical Devices Agency seeking approval for the world’s first interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C. 3 November 2013
Danish insulin giant Novo Nordisk announced on Friday that the US Food and Drug Administration has approved the prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch. 3 November 2013
Japanese drug major Eisai says it has filed an application for its already marketed anti-Alzheimer's drug Aricept (donepezil hydrochloride) in Japan, requesting a new indication expansion to use the agent in the treatment of dementia with Lewy bodies. 1 November 2013
US drugmaker Ariad Pharmaceutical says it temporarily suspending the marketing and commercial distribution of Iclusig (ponatinib), its only marketed product, in the USA. 1 November 2013
The US Food and Drug Administration revealed yesterday that it is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. 1 November 2013
The European Generic medicines Association says it congratulates the European Medicines Agency and its Biosimilar Medicines Working Party for organizing a multi-stakeholder workshop, which took place yesterday, to discuss biosimilar guidelines which are at different stages of revision. 1 November 2013
US health care giant Johnson & Johnson subsidiary Janssen-Cilag International has submitted a Marketing Authorization Application to the European Medicines Agency for ibrutinib for the treatment of adult patients with two forms of blood cancer. 31 October 2013
Tougher regulations proposed this month by the US Food and Drug Administration regarding combination drugs that contain hydrocodone as an active ingredient could dampen sales as prescribing restrictions increase, according to Fitch Ratings. 30 October 2013
South Africa’s National Association of Pharmaceutical Manufacturers (NAPM) held a workshop for health care practitioners at the Johannesburg Country Club earlier this month, titled Generics, Get the Facts Straight. 29 October 2013
Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation has received Orphan Drug designation from the US Food and Drug Administration. 29 October 2013
Danish CNS drug specialist Lundbeck says that the US Food and Drug Administration has approved its Sabril (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older. 29 October 2013
Shares of Zogenix rocketed on Friday after the US Food and Drug Administration approved Zohydro ER extended-release capsules for pain management. 28 October 2013
Following swiftly on a similar decision for Janssen’s hepatitis C drug simeprevir, the US Food and Drug Administration’s Antiviral Drugs Advisory Committee on Friday gave its unanimous backing for biotech firm Gilead Sciences sofosbuvir. 27 October 2013
At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a number of recommendations, including positive opinions for Opsumit and Brintellix. 27 October 2013
Danish insulin giant Novo Nordisk said on Friday that it is recalling certain batches of its prefilled insulin product NovoMix30 FlexPen for the treatment of diabetes in Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia. 27 October 2013
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of sofosbuvir, for chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use program. 25 October 2013