Archive


Category: regulatory approval

  • Dream result for Idorsia as FDA clears its insomnia drug

    Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. The US regulator has cleared two doses of dual orexin receptor antagonist (DORA) Quviviq (daridorexant) – 25 mg and 50 mg – for the treatment […]

  • Leo puts target on Dupixent in US as FDA clears tralokinumab

    Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. The […]

  • Novartis bags elusive US approval for cholesterol drug inclisiran

    At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year […]

  • Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab

    The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed phase 3 trial. Another phase 3 study supported the efficacy of the first-in-class TSLP inhibitor as an add-on treatment for people aged 12 and over with severe asthma, as did […]

  • BMS’ Orencia gets FDA nod for GvHD thanks to real-world data

    Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. Orencia (abatacept) becomes the first drug to be approved to prevent GvHD, a condition in which donor immune cells […]

  • EU gives narrower label to Apellis, Sobi’s PNH drug

    Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The European Commission has cleared the complement C3 inhibitor as Aspaveli for the treatment of adults with PNH who are anaemic, but only after they have been […]

  • EU approves Roche’s Actemra for severe COVID-19

    The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours of a recommendation from its advisory committee. Actemra (tocilizumab) has been approved for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical […]

  • Merck claims another adjuvant okay from FDA for Keytruda

    Merck & Co’s strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for adjuvant treatment of skin cancer melanoma. The US regulator has approved Keytruda (pembrolizumab) as a treatment for melanoma patents aged 12 and over with stage 2B, 2C and 3 tumours […]

  • MHRA okays GSK’s Xevudy as data suggest it works against Omicron

    The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light […]

  • Roche, Blueprint’s RET cancer drug Gavreto cleared in EU

    Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the European Commission. Gavreto (pralsetinib) has been cleared as a first-line treatment of people with RET fusion-positive advanced non-small cell lung cancer (NSCLC), a disease that is diagnosed in around 37,000 […]

  • Merck wins FDA nod for Keytruda as adjuvant kidney cancer treatment

    Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA greenlit use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). The checkpoint inhibitor has been approved for use after surgery in patients with RCC – the […]

  • Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia

    Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year […]

  • First launch for Daiichi Sankyo’s oncolytic virus Delytact in Japan

    Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive form of brain cancer. Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing […]

  • AbbVie claims first FDA okay for presbyopia drug therapy

    The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves difficulty in focusing on near objects. The approval has been granted to Vuity (formerly AGN-190584), a one-daily eyedrop formulation of muscarinic cholinergic agonist pilocarpine developed by AbbVie’s Allergen unit that […]

  • Merck gets EU approval for Keytruda in triple-negative breast cancer

    Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. The […]

  • FDA clears first “interchangeable” Humira biosimilar

    Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. Cyltezo has been approved in the US since 2017 for several of the approved indications for Humira (adalimumab) but […]

  • Roche scores early adjuvant lung cancer approval for Tecentriq

    Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or […]

  • Flash FDA approval sends ChemoCentryx spiralling upwards

    ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. Avacopan will be launched as Tavneos in the coming weeks as a treatment for two forms of ANCA vasculitis – granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) – in […]

  • Kite claims a first for CAR-T Tecartus in adult leukaemia

    The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy an option for an entirely new group of patients. The regulator cleared Tecartus (brexucabtagene autoleucel) for the new indication after a swift review that focused on the ZUMA-3 trial, which […]

  • Takeda bags Japanese approval for Crohn’s cell therapy Alofisel

    Takeda has chalked up another milestone for its Alofisel cell therapy for a complication of Crohn’s disease, becoming the first allogeneic stem cell therapy to be approved in Japan. Alofisel (darvadstrocel) has been cleared by the Ministry of Health, Labour and Welfare (MHLW) for the treatment of complex perianal fistulas in patients with non-active or […]

  • Incyte leads JAK push into eczema as FDA clears Opzelura cream

    The FDA has approved Incyte’s Opzelura cream for atopic dermatitis, commonly called eczema, becoming the first and only topical JAK inhibitor registered in the US. Opzelura (ruxolitinib) – which has been cleared to treat atopic dermatitis in adolescents and adults whose symptoms cannot be treated using other topical therapies – has beaten its orally-administered rivals […]

  • FDA clears Seagen, Genmab’s Tivdak ADC for cervical cancer

    Antibody-drug conjugate (ADC) specialist Seagen has claimed its fourth product approval in the US, getting the nod from the FDA for Tivdak as a second-line monotherapy for recurrent or metastatic cervical cancer. The accelerated approval for Tivdak (tisotumab vedotin) is for women whose cancer has progressed on or after first-line chemotherapy, according to the two […]

  • FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

    Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two […]

  • Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval

    Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung […]

  • Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo

    Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The green light covers England, Scotland Wales, as Northern Ireland remains under the EU regulatory framework, and covers once-daily use of the orally-active drug in adolescents aged over 12 […]

  • FDA clears J&J’s twice-yearly Invega for schizophrenia

    One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem. The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the […]

  • Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU

    Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. The European Commission has approved tafasitamab in combination with Bristol-Myers Squibb’s Revlimid (lenalidomide), followed by the antibody on its own, for the treatment of […]

  • AbbVie’s Rinvoq is first JAK drug cleared in EU for atopic dermatitis

    The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie’s Rinvoq. The EU regulator has cleared Rinvoq (upadacitinib) as an oral treatment for moderate to severe atopic dermatitis in adults and adolescents 12 years and older, either […]

  • Cara’s Korsuva is first drug cleared for itching in dialysis patients

    One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review. The green […]

  • IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis

    UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. The European Commission has cleared the drug as Bimzelx for the treatment of moderate to severe plaque psoriasis […]

  • FDA grants full approval to Pfizer/BioNTech COVID jab

    Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, […]

  • COVID prompts another milestone, as India clears first DNA vaccine

    The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. This is the first DNA vaccine to ever receive regulatory authorisation anywhere in the world, the first COVID-19 jab approved in India to treat children […]

  • BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

    Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who […]

  • After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

    The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from […]

  • Jardiance gets parity with Farxiga in US as FDA clears use in heart failure

    Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in […]

  • GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

    The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – […]

  • Merck’s Welireg becomes first drug for rare VHL tumours in US

    Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 billion takeover of Peloton Therapeutics in 2019 – for a family of rare tumours. The drug is part of Merck’s efforts to expand its oncology portfolio […]

  • Sanofi extends its Pompe range with first Nexviazyme OK

    Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. The US regulator has approved Nexviazyme (avalglucosidase alfa) for the treatment of patients aged one year of age and older with late-onset Pompe disease, which progressively attacks the heart and […]

  • FDA approves AZ’s anifromulab, ending 10-year lupus drug drought

    AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. Anifrolumab was all-but written off in 2018 after failing the phase 3 TULIP-1 trial, but bounced back with positive data from a second study […]

  • After false start, Merck claims Keytruda approval in early breast cancer

    Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The FDA has given a green light to the use of Keytruda (pembrolizumab) pre-surgery alongside chemotherapy in the neoadjuvant setting, as well […]

  • Bluebird claims EU nod for rare disease therapy Skysona

    Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the nod from the EU regulatory authority. The EMA has cleared Skysona (elivaldogene autotemcel) for use in CALD patients aged under 18 who have an ABCD1 genetic mutation and no matched […]

  • Bayer’s finerenone gets FDA nod for diabetic kidney disease

    Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market.  The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market […]

  • Merck pulls Keytruda’s FDA nod for third-line stomach cancer

    Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this setting were a bust.  The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment […]

  • FDA looks at pulling speedy approvals for three cancer drugs

    FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.  The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq […]

  • MHRA approves Seagen’s oral HER2 drug Tukysa

    The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after it was given a green light by the European Commission.  Tukysa (tucatinib) – an orally-active HER2 inhibitor – can be used in combination with anti-HER2 antibody trastuzumab and chemotherapy capecitabine in patients treated with two prior anti-HER2 […]

  • Sobi gets EU nod for Doptelet in rare blood disorder ITP

    Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug. Doptelet (avatrombopag) – an oral thrombopoietin receptor agonist – has been cleared to boost depleted levels of platelets in the blood of patients with ITP, an autoimmune clotting disorder […]

  • Roche claims EU okay for Herceptin/Perjeta combination Phesgo

    Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition. Phesgo combines the anti-HER2 antibodies in Herceptin (trastuzumab) and Perjeta (pertuzumab) in a subcutaneous injection that takes a few […]

  • Vertex gets EU okay to treat younger cystic fibrosis patients

    A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies […]

  • GSK moves further ahead in BCMA with EU okay for Blenrep

    GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients […]