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Showing 15 posts of 1442 posts found.

fdaoutsideweb

FDA approves Sanofi’s Libtayo for advanced basal cell carcinoma

February 10, 2021
Research 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 …

News
gocovri

Adamas’ Parkinson’s drug gets US marketing authorisation for second indication

February 2, 2021
Manufacturing 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 …

News
janssen_latest_logo_on_sign

FDA approves Janssen’s AL amyloidosis drug

January 18, 2021
Sales 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 …

News

Novartis’ ligelizumab granted FDA Breakthrough Therapy Designation

January 14, 2021
FDA, Novartis

The FDA has granted Novartis’ ligelizumab Breakthrough Therapy Designation for the treatment of chronic spontaneous urticaria (CSU) in patients who …

News
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AstraZeneca’s Farxiga granted Priority Review by FDA

January 6, 2021
Research 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 …

News
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AstraZeneca’s cancer drug Tagrisso gets FDA approval

December 21, 2020
Sales 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 …

News
fda2outsideweb

Moderna’s COVID-19 vaccine receives emergency approval from FDA

December 21, 2020
Sales 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 …

News

FDA says Pfizer vaccine vials contain extra doses, boosting US supply

December 17, 2020
Sales 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 …

News
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FDA panel backs Novartis’ Entresto for different form of heart disease

December 16, 2020
Research 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 …

News
fdaoutsideweb

FDA issues emergency use authorisation for Pfizer-BioNTech vaccine

December 14, 2020
Sales 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 …

News

FDA advisory panel recommends US approval of Pfizer/BioNTech’s COVID-19 vaccine

December 11, 2020
Medical 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 …

News
dw-anzcxqaqavhl

FDA approves Novo Nordisk’s Saxenda for adolescent obesity

December 7, 2020
Sales 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 …

News

FDA approves BioCryst’s Orladeyo for reducing hereditary angioedema attacks

December 4, 2020
Medical Communications, Sales and Marketing BioCryst, FDA, Orladeyo

BioCryst has scored FDA for its therapy Orladeyo (berotralstat) for reducing or preventing hereditary angioedema (HAE) attacks in patients over …

News

Roche secures emergency FDA approval for COVID-19 antibody test

December 3, 2020
Sales and Marketing COVID-19, FDA, Roche

The FDA has awarded Emergency Use Authorization to Roche’s COVID-19 test to allow users in the US to analyse the …

News
fdaoutsideweb

FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s

December 2, 2020
Research and Development, Sales and Marketing FDA, Gavreto, Roche

The FDA has awarded accelerated approval to Roche and Blueprint Medicines’ Gavreto (pralsetinib) for the treatment of advanced or metastatic …

News
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