Regulatory Affairs

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Seattle Genetics, Astellas get FDA breakthrough therapy designation for enfortumab vedotin locally advanced or metastatic urothelial cancer
Seattle Genetics, and Astellas Pharma have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for enfortumab vedotin, an antibody-drug conjugate (ADC), to treat patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).
Regulatory Affairs > News
Soligenix gets orphan drug designation from European Commission for RiVax to prevent Ricin poisoning
The European Commission has granted orphan drug designation to the Soligenix recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax) for the prevention of ricin poisoning.
Regulatory Affairs > News
FDA expands approval for Novartis’ Tasigna to treat children with rare form of leukemia
The US Food and Drug Administration (FDA) has expanded the indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
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Sun Pharma gets FDA nod for Ilumya to treat moderate-to-severe plaque psoriasis
By PBR Staff Writer
India-based Sun Pharma has secured approval from the US Food and Drug Administration (FDA) for Ilumya (tildrakizumab-asmn) to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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FDA expands approval of Seattle Genetics’ Adcetris for advanced classical Hodgkin Lymphoma
By PBR Staff Writer
Seattle Genetics’ Adcetris (Brentuximab Vedotin) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).
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FDA grants Xtandi priority review for Nonmetastatic CRPC
The US Food and Drug Administration (FDA) has accepted Pfizer and Astellas Pharma's supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for a new indication and granted priority review designation.
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FDA approves Hizentra to treat chronic inflammatory demyelinating polyneuropathy
The US Food and Drug Administration (FDA) has approved CSL Behring’s Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
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Destiny Pharma's XF-73 MRSA drug gets FDA fast track designation
Destiny Pharma’s has secured fast track designation from the US Food and Drug Administration (FDA) for its lead clinical candidate exeporfinium chloride (XF-73) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA).
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Proteostasis' PTI-428 gets FDA orphan drug designation to treat cystic fibrosis
Proteostasis Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its PTI-428, which is a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier drug candidate.
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FDA puts clinical hold on Solid Biosciences' Duchenne gene therapy trial
By PBR Staff Writer
The US Food and Drug Administration (FDA) has placed a clinical hold on Solid Biosciences' IGNITE DMD phase Phase I/II trial for SGT-001 microdystrophin gene transfer in Duchenne muscular dystrophy (DMD).
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FDA grants priority review to Merck’s Keytruda for cervical cancer
By PBR Staff Writer
Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of advanced cervical cancer.
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FDA upholds decision on generic version of GSK’s asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
The US Food and Drug Administration (FDA) has upheld the earlier decision of turning down Hikma and Vectura’s generic version of GlaxoSmithKline's (GSK) Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
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FDA committee votes in favor of Pfizer's Xeljanz for ulcerative colitis
By PBR Staff Writer
Pfizer has received a positive response from the Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) on Xeljanz (tofacitinib) to treat adult patients with moderately to severely active ulcerative colitis (UC).
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Bristol-Myers secures FDA approval for new dosing of cancer drug Opdivo
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a four-week dosing schedule for Bristol-Myers Squibb's Opdivo cancer drug.
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EMA to review AstraZeneca’s Forxiga for type-1 diabetes
The European Medicines Agency (EMA) has accepted AstraZeneca's marketing authorisation variation for its selective SGLT-2 inhibitor Forxiga (dapagliflozin) for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
Regulatory Affairs > News
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