ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.
Pfizer has secured approval the European Commission (EC) for TRUMENBA (Meningococcal Group B Vaccine) for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.
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.
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin (pem/carbo) has been approved by the US Food and Drug Administration (FDA) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.
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.
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).
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