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Halozyme Announces FDA Accepted BLA for Fixed-Dose Subcutaneous Perjeta, Herceptin Combination americanpharmaceuticalreview
March 05, 2020
Halozyme Therapeutics announced the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech ...
FDA Approves Neratinib for Metastatic HER2-Positive Breast Cancer americanpharmaceuticalreview
March 05, 2020
The Food and Drug Administration (FDA) approved neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer ...
Amphastar Receives FDA Approval for Supplement to ANDA for Sodium Bicarbonate Injection americanpharmaceuticalreview
March 05, 2020
Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) granted approval of its supplemental Abbreviated New Drug Application for Sodium Bicarbonate Injection ...
WPD Pharmaceuticals’ Brain Cancer Drug Received Positive FDA Pre-IND Guidance americanpharmaceuticalreview
March 05, 2020
WPD Pharmaceuticals has provided an update that through its license partner, CNS Pharmaceuticals, it received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND ...
FDA Grants Rare Pediatric Disease Designation to Elamipretide for Barth Syndrome americanpharmaceuticalreview
March 05, 2020
Stealth BioTherapeutics announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth syndrome.
Genentech’s Esbriet gets FDA breakthrough status in uILD pharmaceutical-technology
March 05, 2020
Roche Group unit Genentech has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat unclassifiable interstitial lung disease (uILD) in adults.
Strides receives US FDA approval for Tetracycline Hydrochloride Capsules expresspharma
March 05, 2020
The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals.
FDA Approves Potassium Phosphates Injection americanpharmaceuticalreview
March 04, 2020
CMP Pharma announced its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019.
FDA Approves isatuximab-irfc for Multiple Myeloma americanpharmaceuticalreview
March 04, 2020
The Food and Drug Administration (FDA) approved isatuximab-irfc (SARCLISA, Sanofi-Aventis) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma ...
KemPharm Submits KP415 NDA to FDA for ADHD americanpharmaceuticalreview
March 04, 2020
KemPharm has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its investigational product candidate, KP415, to the U.S. Food and Drug Administration (FDA).

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