Regulatory Affairs

Regulatory Affairs News

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FDA rejects Sandoz’s BLA for proposed biosimilar rituximab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Sandoz’s biologics licensing application (BLA) for its proposed biosimilar rituximab.
Regulatory Affairs > News
FDA expands approval of Novartis’ Kymriah CAR-T therapy
By PBR Staff Writer
Novartis has secured a second approval for Kymriah (tisagenlecleucel) in the US for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma who had more than two lines of systemic therapy.
Regulatory Affairs > News
FDA grants priority review for Keytruda, chemotherapy combination in NSCLC
Merck said that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy Keytruda based on the results of the phase 3 KEYNOTE-189 trial.
Regulatory Affairs > News
AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Regulatory Affairs > News
ValiRx secures EU patent grant for VAL201 prostate cancer treatment
By PBR Staff Writer
ValiRx has secured a patent grant from the European Union (EU) for its prostate cancer treatment, VAL201, which is currently under clinical studies.
Regulatory Affairs > News
FDA expands GSK’s Trelegy Ellipta indication in COPD
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
Regulatory Affairs > News
Pfizer biosimilar of Roche's cancer drug fails to get FDA approval
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information.
Regulatory Affairs > News
Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims
Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.
Regulatory Affairs > News
FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors
By PBR Staff Writer
Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
Regulatory Affairs > News
BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.
Regulatory Affairs > News
FDA approves Clovis’ Rubraca for recurrent ovarian cancer
The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Regulatory Affairs > News
Indivior files patent lawsuits against Teva, Dr Reddy's and others
Indivior has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,931,305 (the '305 patent) relating to their respective proposed generic versions of the company's Suboxone (buprenorphine and naloxone) sublingual film product.
Regulatory Affairs > News
Proteostasis’ triple combination program secures FDA fast track status for cystic fibrosis
Proteostasis Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its triple combination program to treat cystic fibrosis.
Regulatory Affairs > News
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