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31-45 of 1875 results
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
Production & Manufacturing > Process & Production > News
Omeros’ OMS721 kidney drug gets FDA breakthrough therapy status
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 Immunoglobulin A (IgA) nephropathy.
Production & Manufacturing > Process & Production > News
FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C
The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Production & Manufacturing > Process & Production > News
Sunovion receives complete response letter from FDA for SUN-101/eFlow for COPD
Sunovion Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), such as chronic bronchitis and/or emphysema.
Production & Manufacturing > Process & Production > News
UK’s NICE recommends Novartis’ Afinitor to treat neuroendocrine tumours
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Afinitor (everolimus) to treat unresectable or metastatic neuroendocrine tumours (NETs) in patients with progressive disease.
Production & Manufacturing > Process & Production > News
EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Amgen submits BLA of migraine prevention drug to FDA
Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News
Bayer lymphoma candidate secures FDA priority review designation
By PBR Staff Writer
Bayer has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).
Production & Manufacturing > Process & Production > News
XyloCor’s cardiovascular gene therapy gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation to XyloCor Therapeutics’ lead product candidate XC001 (AdVEGF-All6A+), a cardiovascular angiogenic gene therapy.
Production & Manufacturing > Process & Production > News
FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients
The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).
Production & Manufacturing > Process & Production > News
AstraZeneca’s bladder cancer drug imfinzi gets accelerated approval from FDA
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer.
Production & Manufacturing > Process & Production > News
Takeda’s Alunbrig granted accelerated approval for Metastatic NSCLC
Takeda Pharmaceutical’s Alunbrig (brigatinib) has secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or are intolerant to crizotinib.
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FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s lorlatinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who were earlier treated with one or more ALK inhibitors.
Production & Manufacturing > Process & Production > News
uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe
uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).
Production & Manufacturing > Process & Production > News
31-45 of 1875 results