FDA
FDA expands Janssen’s Erleada label to cover metastatic castration-sensitive prostate cancer
September 19, 2019Sales and Marketing Cancer, Erleada, FDA, Janssen, pharma, prostate cancer
Janssen has announced that the FDA has expanded the label of its androgen receptor inhibitor Erleada (apalutamide) to include the …
US, Canada and Australia simultaneously fast-track Keytruda/Lenvima combo for endometrial cancer
September 18, 2019Research and Development, Sales and Marketing Australian Therapeutic Goods Administration, Cancer, FDA, Health Canada, Lenvima, keytruda, pharma
The FDA has acted under a new initiative in collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, …
Roche bags FDA Breakthrough for Gazyva in lupus nephritis
September 18, 2019Research and Development FDA, Gazyva, Roche, lupus nephritis
The US FDA has granted Breakthrough Therapy Designation to Gazyva (obinutuzumab) for adults with lupus nephritis. The win comes on …
Aimmune’s peanut allergy therapy recommended for approval by FDA committee
September 16, 2019Sales and Marketing Aimmune, FDA, peanut allergy, pharma
The FDA’s Allergenic Products Advisory Committee (APAC) has recommended the use of Aimmune Therapeutics’ AR101, also known by its proposed …
Boehringer’s Ofev scores first-of-its-kind FDA approval in rare lung disease
September 10, 2019Manufacturing and Production, Sales and Marketing Boehringer Ingelheim, FDA, US, lungs, ofev, pharma, rare disease
Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of …
Trump’s FDA: Is the US regulator being steered by the President?
September 9, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump, US, drug safety, pharma
FDA activity has fallen under Donald Trump, with the number of warning letters issued by the regulator dropping by a …
Cancer drugs have surged since the 80s to account for 1 in 4 FDA approvals, report reveals
September 5, 2019Research and Development, Sales and Marketing Cancer, FDA, US, pharma
The number of cancer drug approvals in the US has surged over the last decade to account for over one …
Mylan gets provisional FDA greenlight for generic version of Lilly’s blockbuster cancer drug Alimta
September 2, 2019Sales and Marketing Alimta, Cancer, Eli Lilly, FDA, Mylan, pharma
Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster …
FDA warns three Hepatitis C drugs may worsen liver function in some rare cases
August 29, 2019Medical Communications, Research and Development AbbVie, FDA, Gilead, HCV, MSD, hepatitis C, public health
The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function …
Alexion’s Soliris scoops up expanded EU approval in neuromyelitis optica spectrum disorder
August 28, 2019Research and Development, Sales and Marketing Alexion, FDA, US, pharma, soliris
Alexion has announced the expanded EU approval of Soliris (eculizumab) as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in …
Novartis exec pushed out over Zolgensma data scandal denies wrongdoing
August 21, 2019Research and Development AveXis, FDA, Novartis, Zolgensma, data scandal, pharma, sma
Dr Brian Kaspar, the Novartis exec pushed out of AveXis over the Zolgensma data scandal, has said in a statement …
California man gets eight years in prison for falsely labelling erectile dysfunction drug
August 20, 2019Manufacturing and Production FDA, erectile dysfunction, labellnig, pharma, tadalafil
A man from Walnut, California has been sentenced to eight years and four months in federal prison for illegally importing …
FDA turns down Sarepta’s DMD drug over safety concerns
August 20, 2019Manufacturing and Production DMD, FDA, approval safety, pharma, sarepta
The FDA has declined to approve Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug, citing safety concerns including risk of infection …
FDA greenlights Nebriva’s Xenleta for community-acquired bacterial pneumonia
August 20, 2019Manufacturing and Production, Sales and Marketing FDA, Nabriva, US, Xenleta, pharma, pneumonia
The FDA has awarded approval in the US to Nebriva Therapeutics’ Xenleta (lefamulin) for the treatment of adult patients with …
Celgene’s Inrebic becomes second FDA-approved therapy for rare bone marrow disorder
August 19, 2019Sales and Marketing Cancer, Cerlgene, FDA, Inrebic, pharma, rare disease
Celgene is celebrating the approval in the US of its Janus kinase (JAK) 2 inhibitor Inrebic (fedratinib) in the treatment …
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