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Generics
Shares in India-based Cadila Healthcare 17% on the Bombay Stock Exchange Thursday following the announcement the company has received a warning letter from the US Food and Drug Administration (FDA) regarding irregularities at its manufacturing facilities. 31 December 2015
Biotechnology
Biotech firm Zealand Pharma on Wednesday said it is set to receive a $20 million milestone payment from the French drug major Sanofi following the submission of a New Drug Application for LixiLan to the US Food and Drug Administration. 23 December 2015
Pharmaceutical
Germany’s Merck and US pharma giant Pfizer on Tuesday announced the opening of trial sites for an international Phase III study of avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/ refractory ovarian
cancer. 23 December 2015
Pharmaceutical
Randomized clinical trials (RCTs) have represented, for a long time, the gold standard for clinical trials and the fundamental basis for attaining US Food and Drug Administration approval. However, the major players in health markets are no longer satisfied with meeting safety and efficacy requirements, but are also seeking treatments with better real world effectiveness, comments Dr Nicola Davies in her monthly exclusive for The Pharma Letter. 22 December 2015
Pharmaceutical
The US Food and Drug Administration has approved an expanded indication for Merck’s Keytruda (pembrolizumab) to include the first-line treatment of patients with unresectable or metastatic melanoma. 21 December 2015
Pharmaceutical
UK-based Vernalis on Monday said it has completed the pivotal single-dose comparative bioavailability study for its drug candidate to treat cough and cold. 21 December 2015
Generics
Shares in Indian drug maker Sun Pharmaceutical fell nearly 4.6% on the Bombay Stock Exchange after the company said it has received a warning letter from the US Food and Drug Administration regarding quality control issues at its manufacturing facility in Halol, Gujarat. 21 December 2015
Pharmaceutical
The US Food and Drug Administration has awarded full clearance of Eli Lilly and Boehringer Ingelheim’s insulin glargine injection Basaglar, it has been announced. 17 December 2015
Pharmaceutical
Danish multinational pharmaceutical company Novo Nordisk has submitted a new drug application (NDA) for faster-acting insulin aspart, it has been announced. 9 December 2015
Pharmaceutical
An innovative enzyme replacement therapy (ERT) has become the first treatment for patients with lysosomal acid lipase deficiency (LAL-D) to be approved by the US Food and Drug Administration (FDA), it has been announced. 9 December 2015
Pharmaceutical
Janssen Biotech and Janssen-Cilag International NV have submitted applications to the US Food and Drug Administratio and the European Medicines Agency seeking approval of Stelara (ustekinumab) to treat adult patients with moderately to severely active Crohn’s disease. 1 December 2015
Generics
Shares in India’s Jubilant Life Sciences jumped 10% Tuesday as the company announced the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for antidepressant tablets. 1 December 2015
Biotechnology
India-based Vyome Biosciences plans a regulatory filing by the end of the year with US Food and Drug Administration for its lead molecule (VB 1953), which targets the vast drug resistant acne prescription market, co-founder and chief executive N Venkat told The Pharma Letter in an exclusive interview. 30 November 2015
Generics
Indian drugmaker Dr Reddy’s Laboratories said the US Food and Drug Administration have extended the timeline for replying to the warning letter issued to the company to December 7. 27 November 2015
Pharmaceutical
Swiss drug company Roche has said the European Union has given its nod of approval for the company’s Cotellic (cobimetinib) for use in combination with the drug Zelboraf (vemurafenib) to treat advanced melanoma. 26 November 2015
Biotechnology
The reviewers at the US Food and Drug Association are not convinced by the data for biotech company BioMarin Pharmaceuticals' drisapersen, to treat Duchenne muscular dystrophy (DMD), and said the clinical trial data does not show substantial evidence necessary for approval. 23 November 2015
Pharmaceutical
Telesta Therapeutics Inc on Wednesday said it has licenced its therapy to treat high risk non-muscle invasive bladder cancer (NMIBC) to Ipsen for up to $137 million in upfront and milestone payments comprising a $10 million upfront payment. 28 October 2015
Pharmaceutical
Shares in US drugmaker AbbVie dropped to close down over 10% following a US Food and Drug Association warning the company’s hepatitis C drugs Viekira Pak can lead to serious liver damage for patients with underlying advanced liver disease. 23 October 2015
Biotechnology
Rebiotix Inc said its lead product to treat gastrointestinal (GI) infection has been granted Breakthrough Therapy designation by the US Food and Drug Administration. 13 October 2015
Pharmaceutical
US drug major Eli Lilly on Thursday said the US Food and Drug Administration has granted Breakthrough Therapy designation to its drug candidate for metastatic breast cancer. 8 October 2015
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
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
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