Harmony Biosciences has announced the US Food and Drug Administration (FDA) has approved...
- FDA approves first non-controlled substance narcolepsy drug
- NICE approves Keytruda combination therapy for NSCLC through CDF
- Novartis defends Zolgensma in face of FDA’s data concerns
- Through time: the breakthroughs changing the course of HIV treatment
- Trouble at Teva: US price-fixing lawsuit adds to generic giant’s woes
Celgene’s bone marrow cancer drug Inrebic secures FDA approval
Celgene has received the US Food and Drug Administration (FDA) approval for the use of its Inrebic (fedratinib) drug to treat adults with myelofibrosis, a rare bone marrow cancer.
FDA approves first non-controlled substance narcolepsy drug
Harmony Biosciences has announced the US Food and Drug Administration (FDA) has approved Wakix (pitolisant) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy.
Genentech gets FDA approval for tumour-agnostic drug Rozlytrek
The US Food and Drug Administration (FDA) has approved Roche division Genentech’s tumour-agnostic drug Rozlytrek, which targets a specific genetic defect called neurotrophic tyrosine receptor kinase (NTRK).
Authorised generics: a poorly known pharma tactic to fend off competition
According to the FDA, there are almost 1,200 authorised generics in the US, and they are currently being approved at a rate of one per week on average.
AstraZeneca announces breakthrough therapy status for Calquence in CLL
AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Calquence (acalabrutinib) to treat chronic lymphocytic leukaemia (CLL).
NICE approves Keytruda combination therapy for NSCLC through CDF
The UK’s healthcare regulator the National Institute of Health and Care Excellence (NICE) has recommended Merck’s Keytruda (pembrolizumab) combined with two chemotherapy drugs, carboplatin and paclitaxel or nabpaclitaxel, be made immediately available to National Health Service (NHS) non-small cell lung cancer (NSCLC) patients through the Cancer Drugs Fund (CDF).
Novartis defends Zolgensma in face of FDA’s data concerns
The US Food and Drug Administration (FDA) has issued a statement regarding data accuracy issues related with Novartis’ biologic license application (BLA) for gene therapy Zolgensma (onasemnogene abeparvovec-xioi).
Through time: the breakthroughs changing the course of HIV treatment
This has been a landmark year for HIV treatment; a seven-year study confirmed that taking ART can prevent transmission between gay couples and a second patient has been effectively cured of HIV after receiving a stem cell transplant as a cancer treatment. Allie Nawrat tracks progress in the decades-long quest to effectively prevent, treat and attempt to cure the disease.
FDA grants breakthrough status to new combination for melanoma
The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation for Nektar Therapeutics’ bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb (BMS)’s Opdivo (nivolumab) to treat melanoma.
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