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Linnaeus Announces FDA Clearance of IND Application for LNS8801 americanpharmaceuticalreview
September 26, 2019
Linnaeus Therapeutics announced the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug application (IND) for LNS8801 ...
Cumberland Announces FDA Orphan Drug Grant Award for Ifetroban americanpharmaceuticalreview
September 26, 2019
Cumberland Pharmaceuticals announced FDA Orphan Drug Grant funding for a new Phase II clinical program. The Company has initiated the clinical development of ifetroban for the treatment ...
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity worldpharmanews
September 26, 2019
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc. ...
Losartan drug recall expanded to include five more lots europeanpharmaceuticalreview
September 26, 2019
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
FDA approves vaccine for smallpox and monkeypox europeanpharmaceuticalreview
September 26, 2019
The US Food and Drug Administration (FDA) has announced the approval of Jynneos, a smallpox and monkeypox vaccine for patients 18 years of age or older at high risk of the condition.
FDA grants RMAT designation to SanBio’s cell therapy pharmaceutical-technology
September 25, 2019
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to SanBio Group’s cell therapy, SB623, to treat chronic neurological motor deficits secondary ...
Tarsius Announces FDA Acceptance of TRS01 IND Application americanpharmaceuticalreview
September 25, 2019
Tarsius Pharma announced the acceptance of its Investigational New Drug (IND) application for TRS01 by the U.S. Food and Drug Administration (FDA).
FDA Statement on Final Guidance to Advance ALS Treatments americanpharmaceuticalreview
September 25, 2019
By Norman E. "Ned" Sharpless M.D., Acting Commissioner of Food and Drugs, Janet Woodcock M.D., Director - Center for Drug Evaluation and Research ...
FDA Approves Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-replicating) for Prevention of Smallpox and Monkeypox Disease in Adults drugs
September 25, 2019
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved Jynneos™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN®, liquid-frozen) for prevention ...
Hovione Reports Successful End-of-Phase 2 Meeting With the FDA contractpharma
September 25, 2019
Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea.

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