Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.
Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Adamis Pharmaceuticals’ Epinephrine Injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) has secured approval from the US Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
The UK National Institute for Health and Care Excellence (NICE) has granted approval for Roche’s breast cancer drug Kadcyla for routine use within the NHS region.
The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.
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).
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).
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