FDA
FDA halts studies for bluebird bio’s sickle cell therapy LentiGlobin
February 24, 2021Research and Development Bluebird Bio, FDA, sickle cell disease
The FDA has put bluebird bio’s LentiGlobin gene therapy programme for sickle cell disease (SCD) on clinical hold, following Suspected …
FDA approves Novartis’ heart failure drug Entresto
February 17, 2021Research and Development FDA, Novartis
The FDA has approved Novartis’ Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalisation for heart failure in …
FDA approves Regeneron’s Evkeeza for HoFH
February 12, 2021Medical Communications FDA, Regeneron
The FDA has approved Regeneron’s Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat …
FDA approves Sanofi’s Libtayo for advanced basal cell carcinoma
February 10, 2021Research and Development Cancer, FDA, Sanofi
The FDA has approved Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell …
Adamas’ Parkinson’s drug gets US marketing authorisation for second indication
February 2, 2021Manufacturing and Production Adamas Pharmaceuticals, FDA
The FDA has granted marketing authorisation for a second indication for Adamas Pharmaceuticals’ Gocovri (amantadine) extended release capsules. The drug …
FDA approves Janssen’s AL amyloidosis drug
January 18, 2021Sales and Marketing FDA, Janssen
The FDA has approved Janssen’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone …
Novartis’ ligelizumab granted FDA Breakthrough Therapy Designation
January 14, 2021FDA, Novartis
The FDA has granted Novartis’ ligelizumab Breakthrough Therapy Designation for the treatment of chronic spontaneous urticaria (CSU) in patients who …
AstraZeneca’s Farxiga granted Priority Review by FDA
January 6, 2021Research and Development AstraZeneca, FDA, farxiga
AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney …
AstraZeneca’s cancer drug Tagrisso gets FDA approval
December 21, 2020Sales and Marketing AstraZeneca, Cancer, FDA
The FDA has approved AstraZeneca’s Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated …
Moderna’s COVID-19 vaccine receives emergency approval from FDA
December 21, 2020Sales and Marketing COVID-19, FDA, Moderna, US, Vaccine
Moderna has announced that the FDA yesterday authorised the emergency use of mRNA-1273, the biotechnology company’s vaccine against COVID-19 in …
FDA says Pfizer vaccine vials contain extra doses, boosting US supply
December 17, 2020Sales and Marketing COVID-19, FDA, Pfizer, Vaccine
The FDA has announced that extra doses contained in Pfizer COVID-19 vaccine vials could expand America’s supply of the jab …
FDA panel backs Novartis’ Entresto for different form of heart disease
December 16, 2020Research and Development FDA, Novartis, heart failure
Novartis’ heart failure drug Entresto has received recommendation from the FDA’s Cardiovascular and Renal Drugs Advisory Committee for use in …
FDA issues emergency use authorisation for Pfizer-BioNTech vaccine
December 14, 2020Sales and Marketing COVID-19, FDA, US, Vaccine
The US Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in those aged 16 and …
FDA advisory panel recommends US approval of Pfizer/BioNTech’s COVID-19 vaccine
December 11, 2020Medical Communications, Sales and Marketing COVID-19, FDA, Vaccine
An advisory panel on behalf of the FDA has strongly recommended that Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 be approved …
FDA approves Novo Nordisk’s Saxenda for adolescent obesity
December 7, 2020Sales and Marketing FDA, Novo Nordisk, saxenda
The FDA has awarded US approval to Novo Nordisk’s Saxenda (liraglutide) 3mg injection to treat obesity in patients between the …
