The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s Zeposia (ozanimod) 0.92mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD). 28 May 2021
Targeted therapies have been a game changer in EGFR-mutated lung cancer, with options such as Tagrisso (osimertinib), from AstraZeneca, helping to greatly improve progression-free survival (PFS). 28 May 2021
Myovant Sciences and Pfizer have announced that the US Food and Drug Administration (FDA) has approved Myfembree (relugolix/estradiol/norethindrone acetate), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. 27 May 2021
The US Food and Drug Administration has granted an Emergency Use Authorization (EUA) for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19. 27 May 2021
The US regulator will consider a submission for novel cancer therapy ciltacabtagene autoleucel (cilta-cel) under the agency’s Priority Review scheme, with a decision expected by November 29. 27 May 2021
The US Food and Drug Administration announced on Wednesday that it is restricting the use of US biotech firm Intercept Pharmaceuticals’ liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. 27 May 2021
AstraZeneca’s planned $39 billion buy of American rare disease specialist Alexion Pharmaceuticals hit a speed bump on Tuesday, after the UK’s antitrust body launched a review of the deal. 26 May 2021
Shares in New Jersey, USA-based company Provention Bio rose by over a quarter on Tuesday, after the firm announced positive regulatory news related to its type 1 diabetes (T1D) candidate teplizumab. 26 May 2021
The European Commission (EC) should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines. 26 May 2021
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib), TG Therapeutics’ once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 26 May 2021
The European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 26 May 2021
Johnson & Johnson subsidiary Janssen has received approval from the European Commission for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 25 May 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Verastem’s investigational RAF/MEK inhibitor VS-6766, combined with defactinib, its FAK inhibitor, in recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. 25 May 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for Boehringer Ingelheim’s BI 425809 for the treatment of cognitive impairment associated with schizophrenia (CIAS). 24 May 2021
The US Food and Drug Administration strictly prohibits the distribution of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, and expired drugs that pose a serious threat to life. Nevertheless, such drugs continue to end up in circulation, compromising patient safety. 24 May 2021
Last Saturday, US biotech Moderna announced that the Ministry of Food and Drug Safety of South Korea (MFDS) has approved the company’s application for conditional marketing authorization for its mRNA vaccine against COVID-19. 24 May 2021
On Friday, the US Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. 22 May 2021
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. 21 May 2021
Following its May 2021 meetings, the European Medicines Agency’s human medicines committee (CHMP) recommended eight even medicines, including one gene therapy and one generic, for approval. 21 May 2021
New storage conditions for the COVID-19 vaccine from Pfizer and Germany’s BioNTech have today been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 21 May 2021
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024