FDA
Dompé gives the FDA its first approved neurotrophic keratitis treatment
August 24, 2018Medical Communications, Sales and Marketing Dompe, FDA, Oxervate, eye disease, pharma
Milan-based biotech firm Dompé has revealed that the FDA has awarded approval in the US to its Oxervate (cenegermin-bkbj ophthalmic …
FDA refuses Allergan’s uterine bleeding therapy with a request for more data
August 22, 2018Research and Development, Sales and Marketing Allergan, Esmya, FDA, pharma
Allergan has shared the news that the FDA has refused to award marketing authorisation to its ulipristal acetate product Esmya …
FDA approves Bristol Myers Squibb’s Opdivo in small-cell lung cancer
August 20, 2018Sales and Marketing Bristol-Myers Squibb, FDA, approval, bristol myers squibb, lung cancer, opdivo
The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), as the first …
Regeneron’s Eylea wins FDA approval for wet age-related macular degeneration
August 20, 2018Sales and Marketing Bayer, Eylea, FDA, Regeneron, US, pharma
Regeneron is celebrating the approval in the US of its vascular endothelial growth factor (VEGF) inhibitor Eylea (aflibercept) for the …
Thyroid medication recalled after Chinese supplier fails inspection
August 20, 2018Sales and Marketing China, FDA, recall, thyroid, westminster
The Mississippi based manufacturer Westminster Pharmaceuticals is voluntarily recalling thyroid medications Levothyroxine and Liothyronine after the Chinese company Sichuan Friendly …
FDA approves first-ever generic EpiPen versions, courtesy of Teva
August 17, 2018Medical Communications, Sales and Marketing FDA, Mylan, Teva, US, epipen, pharma
The FDA has announced the approval of the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine auto-injectors as …
FDA approves RNA therapy for rare genetic disease
August 13, 2018Sales and Marketing FDA, Onpattro, Orphan Drugs, RNA, rare diseases
The US Food and Drug Administration has approved the RNA-based therapy Onpattro, for the treatment of the rare genetic disease …
FDA approves first oral therapy for rare Fabry disease
August 13, 2018Sales and Marketing FDA, Fabry disease, US, pharma
Amicus has revealed that its therapy Galafold (migalastat) has been awarded approval by the FDA in the treatment of adult …
FDA approved more generics in July than any previous month
August 10, 2018Medical Communications FDA, generics, pharma
FDA Commissioner Scott Gottlieb took to Twitter to announce the news that the FDA smashed its previous record for number …
FDA expands list of valsartan recalls
August 9, 2018Medical Communications China, FDA, US, heart medication, recall, valsartan
The US Food and Drug Administration (FDA) has expanded a list of products containing valsartan that are to be recalled. …
FDA announces policy shift to encourage new opioid addiction treatments
August 7, 2018Manufacturing and Production FDA, deaths, opioid crisis, overdose, policy
The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability …
Pain Therapeutics refocuses on Alzheimer’s after FDA turns down abuse-deterrent opioid painkiller
August 7, 2018Manufacturing and Production, Research and Development, Sales and Marketing FDA, Remoxy, opioid crisis, opioids, pain therapeutics, pharma
The FDA has voted to reject Texas-based Pain Therapeutics’ abuse deterrent opioid painkiller Remoxy (oxycodone), leading the company to consider …
Epizyme shuts down failing lymphoma trial as FDA imposes clinical hold
August 3, 2018Medical Communications, Research and Development Epizyme, FDA, lymphoma, pharma, tazemetostat
Epizyme’s Q2 financial results have been derailed by the company’s decision to terminate further Phase 2 development of its lead …
FDA rejects Insys Therapeutics sublingual opioid spray
July 31, 2018Manufacturing and Production Crisis, FDA, insys, opioid, rejection, spray
The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid …
Progenics’ Azedra becomes first FDA-approved treatment for adrenal tumours
July 31, 2018Manufacturing and Production, Sales and Marketing Cancer, FDA, Progenics, adrenal cancer, pharma
The FDA has approved its first-ever drug for rare, unresectable tumours of the adrenal gland with its decision to authorise …
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