Regulatory Affairs

Regulatory Affairs News

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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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
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
Sanofi’s Dupixent to be reviewed by FDA for moderate-to-severe asthma
Sanofi’s supplemental biologics license application of Dupixent (dupilumab) as an add-on maintenance treatment for certain adults and adolescents having moderate-to-severe asthma has been accepted for review by the US Food and Drug Administration (FDA).
Regulatory Affairs > News
Biogen, AbbVie withdraw MS drug Zinbryta over safety concerns
By PBR Staff Writer
Biogen and AbbVie are withdrawing their multiple sclerosis (MS) drug Zinbryta (daclizumab) from global market after reports of eight cases of serious brain inflammation.
Regulatory Affairs > News
Endo wins preliminary injunction against QuVa in vasopressin case
By PBR Staff Writer
Endo International has won a preliminary injunction in the US, barring QuVa Pharm from introducing a compounding drug that could compete with its Vasostrict, the vasopressin injection indicated to increase blood pressure in adults with vasodilatory shock.
Regulatory Affairs > News
FDA approves Sorrento's non-opioid pain patch for post-herpetic neuralgia
By PBR Staff Writer
Sorrento Therapeutics’ subsidiary Scilex Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for non-opioid ZTlido (lidocaine topical system) 1.8% to relieve pain associated with post-herpetic neuralgia (PHN) or post-shingles pain.
Regulatory Affairs > News
FDA rejects Celgene’s NDA for relapsing multiple sclerosis drug ozanimod
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Celgene’s new drug application (NDA) for relapsing multiple sclerosis drug, ozanimod.
Regulatory Affairs > News
Roche's hemophilia drug Hemlibra secures approval in Europe
By PBR Staff Writer
Roche’s Hemlibra (emicizumab) has been approved by the European Commission (EC) as a prophylactic treatment for bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
Regulatory Affairs > News
FDA grants priority review to Shionogi's lusutrombopag
Shionogi's new drug application (NDA) for lusutrombopag (S-888711) has been accepted for filing and granted priority review by the US Food & Drug Administration (FDA).
Regulatory Affairs > News
Lilly’s breast cancer drug Verzenio secures another approval in US
By PBR Staff Writer
Eli Lilly and Company has secured additional approval from the US Food and Drug Administration (FDA) for Verzenio (abemaciclib) as initial treatment for advanced breast cancer.
Regulatory Affairs > News
FDA accepts Destiny Pharma's IND for XF-73 clinical drug candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Destiny Pharma’s investigational new drug application (IND) for its anti-infective clinical drug candidate, XF-73.
Regulatory Affairs > News
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