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Relief Therapeutics Holding AG (RLFTF.OB), a Switzerland-based biopharmaceutical company, on Tuesday, announced that its drug candidate RLF-100 has been granted Orphan Drug Designation by the FDA for use in the treatment of sarcoidosis.

Genentech, a member of the Roche Group (RHHBY.PK), said FDA has granted priority review for Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. The company's application is based on disease-free survival results from an interim analysis of the phase III IMpower010...

Biotechnology company Vaxart, Inc. (VXRT) announced Monday that the U.S. Food and Drug Administration has cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. The vaccine candidate expressing S-only protein produced higher serum antibodies than...

The U.S. Food and Drug Administration approved AstraZeneca plc.'s (AZN.L, AZN) Saphnelo or anifrolumab-fnia for the treatment of adult patients with moderate to severe systemic lupus erythematosus or SLE who are receiving standard therapy. Systemic lupus erythematosus is an autoimmune disease in which...

The U.S. Food and Drug Administration has broadened the Emergency Use Authorization or EUA for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir, Eli Lilly and Co. (LLY) and Incyte (INCY) said in a statement...

Viatris Inc. (VTRS) and Biocon Biologics said that they received an approval from the U.S. Food and Drug Administration for the first Interchangeable Biosimilar Semglee (insulin glargine-yfgn injection) for the treatment of diabetes. The interchangeable Semglee product, which will allow substitution...

The U.S. Food and Drug Administration has approved Merck & Co., Inc.'s (MRK) anti-PD-1 therapy, KEYTRUDA, for the treatment of patients with high-risk early-stage triple-negative breast cancer or TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant...

The U.S. Food and Drug Administration approved AbbVie's (ABBV) Dalvance or dalbavancin for the treatment of acute bacterial skin and skin structure infections or ABSSSI in pediatric patients from birth. Dalvance is the first single-dose option administered as a 30-minute intravenous (IV) infusion...

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending marketing authorization for Moderna Inc.'s (MRNA) COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, the company said in a statement. "The...

The U.S. Food and Drug Administration has approved the combination of Keytruda, Merck's anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high...

Pfizer Inc. (PFE) said on Wednesday that the U.S. Food and Drug Administration or FDA has notified the company that it will not meet the Prescription Drug User Fee Act or PDUFA goal dates for the New Drug Application submitted by the company for abrocitinib for treating adults and adolescents with moderate...

AbbVie (ABBV) announced Wednesday that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation or BTD to venetoclax (VENCLEXTA) in combination with azacitidine in Higher Risk Myelodysplastic Syndrome or MDS. The BTD is granted for the potential treatment of adult patients...

The European Commission has approved Myovant Sciences' (MYOV) the marketing authorization application for RYEQO--relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg-- for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation...

Japan's Ministry of Health, Labour and Welfare has approved Regeneron Pharmaceuticals Inc.'s (REGN) casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. It marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve in other countries,...

SINOVAC Biotech Ltd. (SVA) said Monday it received a drug registration approval from the National Medical Product Administration of China or "NMPA" for its Sabin strain based inactivated polio vaccine or "sIPV". The company expects that the vaccine will be available on the market by the end of 2021. In...

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