Regulatory Affairs

Regulatory Affairs News

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European Commission approves Perjeta and Herceptin combo
The European Commission (EC) has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery treatment of adults with HER2-positive early breast cancer (eBC) at high risk of recurrence.
Regulatory Affairs > News
Lilly and Incyte gain FDA approval for lower dose of RA drug Olumiant
The US Food and Drug Administration (FDA) has approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase (JAK) inhibitor developed by Lilly and Incyte to treat moderately-to-severely active rheumatoid arthritis (RA).
Regulatory Affairs > News
Pfizer’s Xeljanz gets FDA approval for ulcerative colitis
By PBR Staff Writer
Pfizer’s Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with moderately to severely active ulcerative colitis.
Regulatory Affairs > News
FDA grants priority review to Loxo's larotrectinib for several solid tumors
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Loxo Oncology’s new drug application (NDA) and granted priority review for larotrectinib to treat adult and pediatric patients with locally advanced or metastatic solid tumors harboring an neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
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EC authorizes Clovis Oncology’s Rubraca to treat women with recurrent ovarian cancer
The European Commission (EC) has authorized Clovis Oncology’s Rubraca (rucaparib) for the treatment of women with recurrenr ovarian cancer.
Regulatory Affairs > News
AB Science plans to resubmit marketing application in Europe for ALS treatment masitinib
By PBR Staff Writer
AB Science is evaluating options to resubmit the marketing authorization application (MAA) in Europe for its amyotrophic lateral sclerosis treatment (ALS), masitinib.
Regulatory Affairs > News
EC approves Sandoz' Zessly to treat gastroenterological, rheumatological and dermatological diseases
Sandoz has secured approval from the European Commission for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
Regulatory Affairs > News
BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) Injection for the treatment of adults with phenylketonuria (PKU), a serious genetic disease.
Regulatory Affairs > News
FDA declines to approve Cosmo’s NDA for Methylene Blue MMX
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Cosmo Pharmaceuticals, saying that it cannot approve the latter’s Methylene Blue MMX as a visualization aid to increase detection of lesions in the colon.
Regulatory Affairs > News
FDA to review Zynquista as potential treatment for type 1 diabetes
The US Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin).
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ViiV Healthcare gets EC approval for Juluca to treat HIV-1 infection
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured marketing approval from the European Commission (EC) for Juluca (dolutegravir 50mg/rilpivirine 25mg) to treat human immunodeficiency virus type 1 (HIV-1) infection.
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FDA approves Dova’s Doptelet for thrombocytopenia in adults with CLD
By PBR Staff Writer
Dova Pharmaceuticals’ subsidiary AkaRx has secured approval from the US Food and Drug Administration (FDA) for its Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in patients with chronic liver disease (CLD).
Regulatory Affairs > News
FDA approves AstraZeneca’s Lokelma to treat hyperkalemia in adults
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
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Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer
The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).
Regulatory Affairs > News
Novartis and Amgen secure FDA approval for migraine drug
By PBR Staff Writer
Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.
Regulatory Affairs > News
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