Regulatory Affairs

Regulatory Affairs News

View news from other Pharmaceutical sectors:
121-135 of 3712 results
Astellas’ gilteritinib gets orphan designation in Europe for acute myeloid leukaemia
Astellas Pharma's gilteritinib has secured orphan designation from the European Commission (EC) to treat patients with acute myeloid leukaemia (AML).
Regulatory Affairs > News
Sobi’s metabolic disorder drug secures fast track status in US
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Swedish Orphan Biovitrum's (Sobi) new drug application and granted fast track status for mucopolysaccharidosis type IIIA (MPS IIIA) drug candidate SOBI003.
Regulatory Affairs > News
Bristol-Myers’ Yervoy approved in Europe for pediatric melanoma
The European Commission (EC) has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for the treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma.
Regulatory Affairs > News
FDA grants priority review for daratumumab in front line multiple myeloma
Genmab announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Regulatory Affairs > News
AstraZeneca secures approvals for cancer and asthma drugs in Japan
By PBR Staff Writer
AstraZeneca has secured approvals for its cancer drug Lynparza (olaparib) and asthma drug Fasenra (benralizumab) from the Japanese Ministry of Health, Labour and Welfare for the treatments of ovarian cancer and bronchial asthma, respectively.
Regulatory Affairs > News
USPTO invalidates J&J’s patent on prostate cancer drug Zytiga
By PBR Staff Writer
The US Patent & Trademark Office (USPTO) has invalidated a Johnson & Johnson (J&J) patent on prostate cancer drug Zytiga (abiraterone acetate).
Regulatory Affairs > News
Novartis’ Kymriah nabs speedy reviews in US, Europe for lymphoma treatment
By PBR Staff Writer
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Regulatory Affairs > News
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
Sandoz, a Novartis division, announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.
Regulatory Affairs > News
Shire’s haemophilia A drug Adynovi secures approval in Europe
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
Regulatory Affairs > News
Midatech gets FDA IND approval to begin trial of brain cancer treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Midatech Pharma’s investigational new drug (IND) application to carry out a study of an investigational nano-inclusion product, MTX110, to treat fatal childhood brain cancer DIPG.
Regulatory Affairs > News
FDA approves Lynparza in germline BRCA-mutated metastatic breast cancer
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
Regulatory Affairs > News
Endo receives subpoena from US Attorney Office on products featuring oxymorphone
Endo International's subsidiary Endo Pharmaceuticals has received a grand jury subpoena from the US Attorney's Office for the Southern District of Florida seeking documents and information relating to products containing oxymorphone.
Regulatory Affairs > News
FDA panel votes against approval of Lipocine’s testosterone replacement therapy
The US Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has decided not to recommend the approval of Lipocine's TLANDO.
Regulatory Affairs > News
AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.
Regulatory Affairs > News
Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO, Testosterone Replacement Therapy in Adult Males with Hypogonadism
Lipocine Inc., a specialty pharmaceutical company, announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
Regulatory Affairs > News
121-135 of 3712 results