Approvals

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.

FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia

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.

FDA approves Merck’s Keytruda for cancer patients with certain biomarkers

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 approved by FDA for giant cell arteritis treatment

Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.

EC launches probe into Aspen’s pricing practices for cancer drugs

The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.

Merck’s Keytruda in combination with chemotherapy gets FDA nod to treat NSCLC

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.

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.

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).

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.