FDA Updates for the Week of Nov. 14, 2022
November 19th 2022In a busy week, the FDA approved the first drug to delay diabetes, a second interchangeable Lantus biosimilar, and an alternate dosing schedule for Rylaze. The agency also granted accelerated approval of a novel ovarian cancer therapy, updated the target date for pegcetacoplan NDA review, and proposed prescription-to-OTC naloxone. In addition, an advisory committee supported the use of Xphozah in CKD.
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FDA Updates for Week of Nov. 7, 2022
November 12th 2022The FDA approved several new therapies for cancers, including the combination of Imfinzi and Imjudo to treat lung cancer, Libtayo for second indication in lung cancer, and Adcetris for younger patients with Hodgkin lymphoma. In COVID-19 news, the agency issued an EUA for Kineret for hospitalized, but indicated bebtelovimab does not neutralize new omicron subvariants. The regulatory agency also accepted NDAs for a Parkinson’s disease therapy and for a therapy used for stem cell mobilization.
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FDA Updates for the Week of Oct. 31, 2022
November 5th 2022The FDA has approved a hepatitis B therapy for adolescents and an oral MEK inhibitor to treat blood cancers. The regulatory agency has granted priority review for an adult RSV vaccine but extended the review for a Pompe disease therapy. Additionally, CytoDyn has withdrawn its BLA for an HIV therapy.
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FDA Updates for Week of Oct. 24, 2022
October 29th 2022The FDA approved two new novel cancer treatments: a bispecific antibody for multiple myeloma and a regimen of two drugs for liver cancer. The agency also granted priority review to two therapies. One is a novel therapy for C. difficile and the other is for a acute myeloid leukemia drug. The FDA has postponed an advisory committee meeting for an OTC birth control pill and accepted an NDA for new dry eye therapy. Additionally, Genmab submitted applications for a bispecific therapy for large B-cell lymphoma.
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FDA Updates for Week of Oct. 10, 2022
October 15th 2022In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.
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FDA Updates for Week of October 3, 2022
October 8th 2022The FDA uses real-world data to show how Boostrix prevents infections in infants. The agency also approves a label expansion for Oxlumo, a new administration method for Trogarzo, and accepts an sBLA for Takhzyro. In COVID-19 news, Eiger won’t submit EUA for COVID-19 treatment. Additionally, an OIG reports finds many accelerated approvals have delayed confirmatory trials.
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FDA Updates for the Week of Sept. 26, 2022
October 1st 2022The FDA has approved several new therapies this week, including Amylyx’s oral treatment for ALS, a fourth Avastin biosimilar, a new glaucoma treatment and another indication for Duxipent. The agency also accepted an NDA for therapy for rare immunodeficiency disease.
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FDA Updates for the Week of Sept. 19, 2022
September 24th 2022The FDA approved a tumor agnostic treatment for cancer, a lower dose MRI contrast agent, the first generic of Tazorac gel, and a gene therapy for a rare disease. Advisory committees vote down poziotinib for NSCLC and Pepaxto for multiple myeloma and give positive vote for microbiotic-based C. diff therapy. The agency has accepted sNDA for Tukysa for HER2 positive colorectal cancer.
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FDA Updates for the Week of Sept. 12, 2022
September 17th 2022The FDA has approved new therapies for psoriasis and kidney dysfunction. The agency has also scheduled an advisory committee meeting for nonprescription birth control and accepted applications for longer-acting aripiprazole, Rett syndrome drug, and an enzyme replacement therapy. Additionally, Clovis has submits supplemental applications for Rubraca.
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FDA Updates for Week of Sept. 5, 2022
September 10th 2022In COVID-19 news, the FDA indicated Eiger’s treatment not supported by data. An advisory committee switched its vote to yes for new ALS drug. The FDA approved Stimufend, a biosimilar to Neulasta, as well as Imfinzi for biliary tract cancer, a longer-lasting treatment for frown lines, an oral suspension for gastric ulcers, and generics of Revlimid. The agency accepted applications for novel dry eye disease and alopecia therapies. Additionally, Seres completed rolling BLA for microbiome therapeutic.
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FDA Updates for Week of Aug. 29, 2022
September 3rd 2022In COVID-19 news, the FDA authorized updated boosters. The agency also approved several new therapies, including Xenpozyme for a rare genetic disorder, and Pemazyre for myeloid/lymphoid neoplasms, Spevigo for rare type of psoriasis flare. The FDA also expanded Imbruvica’s indication for young children with GVHD and granted priority review for weekly hemophilia A therapy.
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FDA Updates for Week of Aug. 22, 2022
August 27th 2022In COVID-19 news, both Pfizer and Moderna have submitted applications for an updated booster vaccine, and the FDA grants EUA for Novavax vaccine for adolescents. The agency also approved rapid-acting Auvelity for major depression, expanded Imbruvica for young children with GVHD, expanded use of Omnipod 5 for younger children, and accepted an NDA for GSK’s myelofibrosis drug.
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FDA Updates for the Week of Aug. 15, 2022
August 20th 2022In COVID-19 news, Novaxax seeks EUA for vaccine booster. The FDA has approved Bluebird’s $2.8 million gene therapy for blood disease, as well a high-concentration of Hadlima, a Humira biosimilar. The agency has also PDUFA for several products, including Lynparza/abiraterone prostate cancer, Polivy for a blood cancer, and fezolinetant for menopause.
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FDA Updates for the Week of August 8, 2022
August 13th 2022In a busy week, the FDA has approved additional indications for Enhertu, Myfembree and Nubeqa, as well as a tablet form of Calquence. The agency also approved Xofluza for children, issued an EUA for monkeypox vaccine in children, extended the review of omaveloxolone, set up advisory committee meeting for microbiota-based C. diff therapy, and priority review for elacestrant in breast cancer. Additionally, Novaliq submited NDA for dry eye treatment.
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