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Intra-Cellular nabs nod for schizophrenia drug after FDA twists fiercepharma
December 31, 2019
Intra-Cellular Therapies had quite a journey toward an FDA decision on its antipsychotic contender. It involved mixed clinical data, a canceled advisory committee meeting and a three-month review extension.
SK Life Science Announces IND Application Acceptance for Anti-Epileptic Drug Candidate americanpharmaceuticalreview
December 30, 2019
SK Life Science announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for SKL24741, for the treatment of epilepsy.
OWP Announces Second IND Approval for Lamotrigine Liquid Oral Suspension Formulation americanpharmaceuticalreview
December 30, 2019
OWP Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and has submitted for U.S. patent protection ...
Breckenridge Announces Final Approval of ANDA for Rivastigmine Transdermal System americanpharmaceuticalreview
December 30, 2019
Breckenridge Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application for ...
Cumberland Receives FDA Approval for RediTrex™ Product Line americanpharmaceuticalreview
December 30, 2019
Cumberland Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex™, its new line of methotrexate products.
Achieve Life Sciences Completes FDA Meeting on Cytisinicline for Smoking Cessation americanpharmaceuticalreview
December 27, 2019
Achieve Life Sciences announced an update on the cytisinicline clinical development program.Following discussions with the Food and Drug Administration (FDA) ...
Eisai preps for launch with insomnia med Dayvigo after buying out Purdue fiercepharma
December 27, 2019
Once partners with the now-embattled Purdue on an insomnia treatment, Eisai bought a full stake in the drug earlier this year––taking on its full development and marketing costs, too.
AZ, Daiichi grab blockbuster nod for breast cancer med Enhertu fiercepharma
December 27, 2019
For metastatic breast cancer patients who try and fail on multiple treatments, finding options to manage disease is a difficult proposition.
Correvio receives FDA complete response letter for anti-arrhythmic drug Brinavess firstwordpharma
December 25, 2019
Correvio Pharma announced Tuesday that the FDA issued a complete response letter regarding its filing seeking approval of Brinavess (vernakalant) for the rapid conversion of recent-onset atrial fibrillation in adults, sending shares down as much as 12%.
First interoperable, automated insulin dosing controller authorised by FDA europeanpharmaceuticalreview
December 25, 2019
The FDA has authorised the first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customise their diabetes management.

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