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The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Biotechnology
Shares of US genetic meds company MeiraGTx Holdings were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss. 13 November 2024
Pharmaceutical
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. 12 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax revealed yesterday. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program, according to Sarah Wicks and James Valentine at US law firm Hyman, Phelps & McNamara. 11 November 2024
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
The US Food and Drug Administration has approved Korsuva (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, said Cara Therapeutics. 24 August 2021
Biotechnology
More than eight months after first being granted emergency use authorization (EUA), the COVID-19 vaccine from Pfizer and BioNTech has received full approval from the US Food and Drug Administration (FDA). 23 August 2021
Pharmaceutical
The acting Commissioner of the US Food and Drug Administration (FDA) will not get the job permanently, according to a Bloomberg report. 23 August 2021
Pharmaceutical
A key responsibility of the US Food and Drug Admi0nistration is holding pharma companies and other healthcare stakeholders accountable for the safety and efficacy of medicinal products. However, as the furor over the FDA’s approval of Biogen’s aducanumab (Aduhelm) rages on, we are forced to contemplate the accountability of the agency itself. We discuss other instances, from the last three years, in which the FDA was investigated. 23 August 2021
Biotechnology
The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) 240mg every two weeks or 480 mg every four weeks for the adjuvant treatment of urothelial carcinoma (UC) patients at high risk of recurrence after radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. 23 August 2021
Generics
Zydus Cadila, a part of Cadila Healthcare, today announced it has received final approval from the US Food and Drug Administration to market a generic version of US pharma giant Pfizer’s (NYSE: PFE) KAK inhibitor Xeljanz XR (tofacitinib) extended-release tablets, 11mg and 22mg in the USA. 23 August 2021
Pharmaceutical
Last week’s notable news included US cancer drug developer Sesen Bio being battered after it revealed that the US Food and Drug Administration had issued a compete response letter (CRL) relating to its bladder cancer candidate Vicineum. AbbVie announced new clinical trial results on the efficacy of its investigational migraine prevention treatment atogepant. FibroGen and Japanese partner Astellas said they had been granted approval in Europe for their drug Evrenzo (roxadustat) as a treatment for chronic kidney disease, and UK pharma major AstraZeneca released new data on its antibody therapy for COVID-19, AZD7442. 22 August 2021
Pharmaceutical
Drugmakers have been warned by PharmaLex over a change that they will face in the electronic product information that they have to provide to the US Food and Drug Administration (FDA) from mid-September. 20 August 2021
Biotechnology
While people in many parts of the world wait in the hope of receiving their first shot of a COVID-19 vaccine, Americans are to be offered their third dose in an attempt to boost immunity to the virus. 19 August 2021
Pharmaceutical
Partners Boehringer Ingelheim and Eli Lilly have announced that Jardiance (empagliflozin) 10mg has been approved by the US Food and Drug Administration (FDA) to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF). 19 August 2021
Biotechnology
US biotech Qualigen Therapeutic' shares tumbled more than 22% to $1.30 yesterday, after it announced its intention to prioritize its focus to its oncology pipeline that includes QN-247 and RAS-F. 18 August 2021
Biotechnology
The US Food an Drug Administration has approved a new indication for Jemperli (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody from UK pharma major GlaxoSmithKline. 18 August 2021
Pharmaceutical
For many years, artificial intelligence (AI), in particular machine learning, have been touted as potentially transformational technologies for drug discovery and development. 16 August 2021
Biotechnology
The US Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) for certain COVID-19 vaccines to allow for the use of an additional in some immuno-compromised people. 16 August 2021
Biotechnology
Shares of USA-based oncology specialist Sesen Bio were all but annihilated on Friday, after the company revealed a major setback for its lead drug candidate, with the stock falling 57% by close of trading and a further 17.5% to $1.74 in after-hours trading. 16 August 2021
Pharmaceutical
The US Food and Drug Administration has granted approval for Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 16 August 2021
Biotechnology
Among last week’s notable news, US biotech firm bluebird bio revealed a double whammy on Wednesday, when it announced a US Food and Drug Administration clinical hold on its gene therapy Skysona (eli-cel) as well as its decision to pull out of Europe because of difficulties in gaining reimbursement for its products. AstraZeneca and partner FibroGen suffered a setback with the FDA issuing a complete response letter (CRL) on their anemia of chronic kidney disease candidate roxadustat. On the deal-making front, US biotech Seagen last week announced a licensing agreement with China’s RemeGen to develop disitamab vedotin as a treatment for various cancers, worth up to $2.2 billion. mRNA specialist Moderna released new data showing its COVID-19 vaccine Spikevax generated neutralizing antibodies against variants. 15 August 2021
Biotechnology
The US Food and Drug Administration on Friday approved Welireg (belzutifan), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) – a rare kidney disease. 14 August 2021
Pharmaceutical
French drugmaker Ipsen has opted to withdraw its New Drug Application (NDA) for the rare disease drug palovarotene. 13 August 2021
Generics
The US Food and Drug Administration (FDA) has established a public docket to solicit comments on issues related to the agency’s regulation of certain drug products approved under abbreviated new drug applications (ANDAs) before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Amendments. 13 August 2021
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