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Pharmaceutical
The US Food and Drug Administration (FDA) approved expanding the prescribing information for Japanese drugmaker Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 13 February 2025
Pharmaceutical
The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) from Swiss pharma giant Roche’s Genentech subsidiary for an Evrysdi (risdiplam) tablet for people living with spinal muscular atrophy (SMA). 13 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer announced late yesterday. 13 February 2025
Biotechnology
The US Food and Drug Administration approved Gomekli (mirdametinib), from SpringWorks Therapeutics, a kinase inhibitor, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) – a type of tumor that forms on nerves, who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. 12 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Emblaveo (aztreonam and avibactam) as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. 10 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis that was submitted by New Jersey, USA-based Insmed. 6 February 2025
Pharmaceutical
It is fourth time lucky for Supernus Pharmaceuticals, as its Parkinson’s specialist finally receives US approval for Onapgo (apomorphine hydrochloride). 5 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic macular edema (DME), said Swiss pharma giant Roche. 5 February 2025
Biosimilars
The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South Korean firm Celltrion. 3 February 2025
Pharmaceutical
Among significant research news last week, US biotech Allakos reported that it was dropping development of its urticaria candidate AK006 following disappointing Phase I trial results. Also, Merck & Co said it was halting the Winrevair HYPERIO trial in pulmonary arterial hypertension (PAH) early due to positive findings. On the M&A front, Lantheus announced it is expanding its radiopharmaceutial portfolio with the acquisition of Evergreen Theragnostics, and its lead product Octevy, for around $1 billion. Also of note, the US Food Administration (FDA) at last approved Vertex Pharmaceutical’s non-opioid pain drug Journavx (suzetrigine). 2 February 2025
Pharmaceutical
CNS-focused biopharma Axsome Therapeutics has won US Food and Drug Administration (FDA) approval for Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. 31 January 2025
Pharmaceutical
Shares of US drugmaker Vertex Pharmaceuticals jumped 8.4% to $475.00 in after-hours trading yesterday after it announced that the US Food and Drug Administration (FDA) has approved Journavx (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. 31 January 2025
Pharmaceutical
In an important regulatory win for Denmark’s Novo Nordisk, the US Food and Drug Administration (FDA) yesterday approved Ozempic (semaglutide) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). 29 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has named Sara Brenner, a physician and senior official in its medical device division, as acting Commissioner. 28 January 2025
Biotechnology
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the USA as the first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies. 28 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Welireg (belzutifan), Merck & Co’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. 28 January 2025
Biotechnology
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab). 27 January 2025
Pharmaceutical
The Food and Drug Administration (FDA) last week granted the first approval for UK pharma major AstraZeneca’s Datroway (Dato-DXd) in the USA for the treatment of breast cancer. On his first day back in the White House as President of the USA, last Monday Donald Trump announced he was pulling the country out of the World Health Organization (WHO). US giant Johnson & Johnson kicked off the fourth-quarter financial results reporting season by big pharma last week, with better-than-expected figures.US mRNA vaccines specialist Moderna announced another supply contract for its COVID-19 vaccine with the European Union (EU). 26 January 2025
Pharmaceutical
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for elamipretide, a first-in-class mitochondria-targeted therapeutic in development for individuals with Barth syndrome. 24 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Pharmaceutical
A new therapy for Parkinson’s disease (PD), opicapone, will be reviewed by the US Food and Drug Administration for possible marketing approval. 11 July 2019
Pharmaceutical
User-friendly drug formulation specialist Azurity Pharmaceuticals has won US approval for Katerzia (amlodipine) for hypertension and coronary artery disease. 10 July 2019
Biotechnology
A bid from France’s Sanofi to market the anti-CD38 therapy isatuximab will be reviewed by the US regulator, with a decision expected by April 30, 2020. 10 July 2019
Pharmaceutical
French ophthalmic drugmaker NicOx saw its shares rise 3.6% to 5.02 euros this morning, after it revealed receipt of a $3 million milestone payment from US partner Eyevance Pharmaceuticals. 9 July 2019
Biotechnology
Bispecific antibodies are artificial proteins that contain two different antigen-binding sites, allowing them to bind to two different types of antigens at the same time.1 As a result, bispecific antibodies can target several molecules, which potentially provides an advantage over utilizing combination therapies or mixtures of various antibodies, writes Dr Nicola Davies in her exclusive blog for The Pharma Letter. 8 July 2019
Generics
Unperturbed by the regulatory pressure from the US Food and Drug administration, and a series of warning letters issued by the agency over the past few years, Indian generic filings have been rising. 8 July 2019
Pharmaceutical
Deal-making news last week featured Boehringer Ingelheim’s collaboration with Yuhan Corp on a potential treatment for non-alcoholic steatohepatitis (NASH). Additionally, the USA’s OncoSec Medical inked a CAR-T cell therapies deal with the Dana Farber Cancer Institute to target solid tumors. Japan’s Sumitomo Dainippon was forced to give up on its anti-cancer candidate napabucasin, following a DSMB recommendation finding futility. There was good news for Zogenix as the US Food and Drug Administration agreed to the company’s resubmission for Dravet syndrome drug Fintepla. 7 July 2019
Pharmaceutical
Spanish drugmaker Grifols says that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the US Food and Drug Administration. 5 July 2019
Biotechnology
Shares of US clinical-stage drug developer Unum Therapeutics tumbled as much as 23% after the company revealed that the Food and Drug Administration had placed a "clinical hold" on the Phase I trial of its cancer treatment ACTR087. 4 July 2019
Pharmaceutical
Shares of US drugmaker Karyopharm Therapeutics leapt more than 36% to $8.90 by close of trading on Wednesday, after it announced that the US Food and Drug Administration had granted accelerated for its blood cancer drug Xpovio (selinexor). 4 July 2019
Biotechnology
US biotech Gilead Sciences and Belgium-based partner Galapagos both saw their shares go up by close of trading yesterday, after Gilead provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib. 3 July 2019
Pharmaceutical
The US Food and Drug Administration has issued new draft guidance providing recommendations for drugmakers on how to create an Instructions for Use (IFU) document. 2 July 2019
Biotechnology
There was good news for Zogenix after a meeting with the US Food and Drug Administration (FDA). 28 June 2019
Biosimilars
Another biosimilar of one of the world’s best-selling oncology drugs, Avastin (bevacizumab), has been approved by the US Food and Drug Administration (FDA). 28 June 2019
Biotechnology
Danish drugmaker Genmab has won US approval for Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd) to treat people with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). 28 June 2019
Biotechnology
In a historic decision, the US Food and Drug Administration approved Soliris (eculizumab) for a rare neurological disorder. 28 June 2019
Biotechnology
The US Food and Drug Administration yesterday approved the first biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), and thus marking a third approved indication for Dupixent (dupilumab). 27 June 2019
Generics
Less than six months after receiving a US Food and Drug Administration (FDA) warning letter about protocol failures at its Illinois manufacturing plant, Akorn has received another relating to its New Jersey unit. 26 June 2019
Pharmaceutical
Acer Therapeuticssaw its market capitalization shattered after the company said it had received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Edsivo (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS). 26 June 2019
Biotechnology
The US Food and Drug Administration has issued a priority review voucher (PRV) to rare disease specialist AveXis, part of Swiss pharma giant Novartis. 25 June 2019
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