Regulation

Mylan bags FDA’s tentative approval for fixed-dose HIV combo therapy

Mylan has secured tentative approval from the US Food and Drug Administration (FDA) for its fixed-dose HIV combination therapy Dolutegravir/Emtricitabine/Tenofovir Alafenamide (DTG/FTC/TAF 50 mg/200mg/25mg) tablets.

AstraZeneca’s Imfinzi wins FDA approval for lung cancer treatment

AstraZeneca's immunotherapy Imfinzi (durvalumab) has secured approval from the US Food and Drug Administration (FDA) for unresectable stage III non-small cell lung cancer (NSCLC).

GSK’s Fluarix Tetra wins European approval for expanded indication

GSK has secured European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older.

Janssen’s Erleada wins FDA nod for nonmetastatic prostate cancer

Janssen Pharmaceutical’s androgen receptor inhibitor Erleada (apalutamide) has been approved by the US Food and Drug Administration (FDA) for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC).

Novartis’ Cosentyx label expanded to include scalp psoriasis

Novartis has secured approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) label update to include moderate-to-severe scalp psoriasis.

FDA grants breakthrough therapy designation for GSK’s meningitis B vaccine Bexsero

GlaxoSmithKline has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of Invasive Meningococcal Disease (IMD) caused by serogroup B in children 2-10 years of age.

Capricor gets FDA RMAT designation for CAP-1002 to treat Duchenne muscular dystrophy therapy

The US Food and Drug Administration (FDA) has granted the regenerative medicine advanced therapy (RMAT) designation for Capricor Therapeutics’ investigational cell therapy for the treatment, CAP-1002, to treat Duchenne muscular dystrophy.

FDA approves Avycaz to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

The US Food and Drug Administration (FDA) has approved Allergan's supplemental new drug application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Amgen receives CHMP positive opinion to add updated overall survival data to Kyprolis label

Amgen has received a positive opinion from the Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to add updated overall survival data to Kyprolis label.