The FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy. Keytruda was previously approved for several other oncology indications including metastatic non-small cell lung cancer, advanced melanoma, recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma,[…]
Eli Lilly and Incyte Corporation announced that the FDA has approved OLUMIANT (baricitinib) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and[…]
On Monday BioMarin received FDA approval for Palynziq to treat a rare disease known as phenylketonuria. https://seekingalpha.com/article/4177692-biomarin-keeps-fda-approval-train-rolling On Wednesday the FDA approved TherapeuticsMD’s IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. This comes a year after the FDA issued a CRL rejection based[…]
Hi folks, I am publishing my blog a day early due to the holiday weekend. Here are the top regulatory stories for this week: On Monday Dova Pharmaceuticals announced the FDA completed their Priority Review and approved DOPTELET (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to[…]
This was a big week with the approval of three new molecular entities by the FDA while Evolus received a complete response letter. Here is my recap of the top regulatory news stories this week: The FDA approved Amgen’s Aimovig (erenumab-aooe) for the preventive treatment of migraines in adults: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm The FDA approved Pfizer’s Retacrit (epoetin[…]
The FDA approved Novartis’ combination treatment dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. http://www.pharmacytimes.com/news/fda-approves-drug-combination-for-treating-brafpositive-anaplastic-thyroid-cancer The FDA has promised Roche/Genentech a priority review for Tecentriq plus Avastin and chemo for lung cancer, with[…]
This was a pretty busy week with an approval of a new molecular entity for Portola, a second indication approval for Novartis’s Kymriah, several new orphan drug designations, and a complete response letter for Sandoz. Here are the top regulatory news stories for this week: Portola Pharmaceuticals received FDA accelerated approval for once-rejected Andexxa, the[…]
Rigel Pharmaceuticals announced that the FDA approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. https://www.prnewswire.com/news-releases/rigel-announces-fda-approval-of-tavalisse-fostamatinib-disodium-hexahydrate-for-chronic-immune-thrombocytopenia-itp-in-adult-patients-300631702.html Ultragenyx and Kyowa Kirin announced FDA approval of Crysvita® (burosumab-twza) for the treatment of children and adults with X–Linked Hypophosphatemia http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-kyowa-kirin-announce-fda-approval-crysvitar[…]
This was a relatively busy week with new draft guidances, new orphan drug designations, two supplemental approvals, and the lifting of a clinical hold. Here are the top regulatory stories for this week: The Food and Drug Administration has approved the first artificial intelligence software that can decide, without a clinician’s involvement, whether a patient[…]
This week saw the submission of two new NDAs, two complete response letters, and one refusal to file. Here are the top regulatory news stories for this week: Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461, a once-daily, oral investigational medicine with a novel[…]
