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Generics
The US Food and Drug Administration yesterday published the guidance for the pharmaceutical industry entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” 29 September 2020
Biotechnology
The US Food and Drug Administration says it has additional questions about the planned Phase II/III trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial. 28 September 2020
Pharmaceutical
US drugmaker Aquestive Therapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for management of seizure clusters. 28 September 2020
Biotechnology
On Friday, the US Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. 26 September 2020
Pharmaceutical
The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have announced the implementation of an element of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada. 25 September 2020
Biotechnology
Gene therapy specialist Spirovant Sciences, which is ultimately owned by Japan’s Sumitomo Dainippon , says that the US Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease designations to its lead product candidate, SPIRO-2101, for the treatment of cystic fibrosis. 25 September 2020
Biotechnology
The US Food and Drug Administration has granted the coveted Rare Pediatric Disease designation (RPDD) to two bone disease drugs, one from UK-based Mereo BioPharma and the other to US company Innova Therapeutics. 24 September 2020
Pharmaceutical
The US Food and Drug Administration has announced it will require a Boxed Warning for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions. 24 September 2020
Biotechnology
Novartis Gene Therapies, the new name for AveXis - which Swiss pharm giant Novartis acquired in an $8.7 billion deal in 2018, has recently received feedback from the US Food and Drug Administration following its review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA). 23 September 2020
Biotechnology
The US Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for its interleukin (IL)-17 inhibitor bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 September 2020
Biotechnology
The US Food and Drug Administration has accepted and granted Priority Review for Bristol Myers Squibb and bluebird bio’s Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121). 22 September 2020
Generics
Generic drugmaker Hikma Pharmaceuticals has received a minor complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for its US generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder: VR315 [US]). 22 September 2020
Biotechnology
Swiss antibody-drug conjugate specialist ADC Therapeutics has submitted to the US regulator for approval to market loncastuximab tesirine as a third-line option. 22 September 2020
Biotechnology
While British drugmaker AstraZeneca has resumed clinical testing for its coronavirus vaccine candidate in the UK, authorities in the US are set to keep the trial on hold for a few more days at least. 16 September 2020
Pharmaceutical
The US Food and Drug Administration is announcing the finalization of a guidance for industry titled, “Eosinophilic Esophagitis: Developing Drugs for Treatment.” 16 September 2020
Biotechnology
The US Food and Drug Administration has granted Rare Pediatric Disease designation to Ad-RTS-hIL-12 with veledimex (Controlled IL-12) for the investigational treatment of diffuse intrinsic pontine glioma (DIPG), a lethal brain tumor occurring in the pontine region of the brain. 14 September 2020
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding Mallinckrodt's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1). 14 September 2020
Biotechnology
In a statement issued on Saturday, US pharma giant Pfizer and German partner BioNTech announced they have submitted an amended protocol to the US Food and Drug Administration to expand the enrollment of their Phase III pivotal COVID-19 vaccine, dubbed BNT162, trial to up to around 44,000 participants which also allows for the enrollment of new populations. 14 September 2020
Pharmaceutical
Last Friday Blueprint Medicines and partner Genentech, a Roche subsidiary, gained US Food and Drug Administration approval for their lung cancer candidate Gavreto (pralsetinib). On the research front, Merck & Co released new data on a Phase III trial of its unexplained chronic cough drug gefapixant. Also of note, last Tuesday AstraZeneca announced a pause on all global clinical trials of its COVID-19 vaccine candidate, developed with Oxford University, because of one serious side effect in a UK trial participant. This resulted in much speculation on the prospects not just for AZD1222 itself, but also other vaccines under development. The good news here is that on September 12, the UK’s medicines regulator decreed that it was safe to resume clinical trials of AZD1222. 13 September 2020
Generics
The US Food and Drug Administration last week pulled up the local unit of Netherlands-incorporated Mylan for violation of good manufacturing norms, including lapses in handling raw materials and issues related with cleaning of equipment, at its Andhra Pradesh-based manufacturing facility. 11 September 2020
Pharmaceutical
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
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