NEWS 1 JULY 2018

• USFDA NEWS

DRUG	COMPANY	NEWS
Pimavanserin	ACADIA Pharmaceuticals	ACADIA Pharmaceuticals Announces FDA Approval of New Dosing Formulation (Capsule 34 mg) and Strength (10 mg) for NUPLAZID tablets

• EMA NEWS

DRUG	COMPANY	NEWS
Nivolumab	Bristol-Myers Squibb	Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of nivolumab for the Adjuvant Treatment of Adult Patients with Melanoma
Exenatide (Bydureon Bcise)	Astrazeneca	Bydureon receives positive EU CHMP opinion for new BCise device for patients with type-2 diabetes
Liposomal Daunorubicin –Cytarabine (Vyxeos)	Jazz Pharmaceuticals	Vyxeos Receives Positive CHMP Opinion for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia
Neratinib	Puma Biotechnology	Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

 

*For browsing official press releases click on the respective news item.