FDA Archives - Page 61 of 220

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Erasca Granted FDA Orphan Drug Designation For CNS-Penetrant EGFR Inhibitor ERAS-801 For The Treatment Of Malignant Glioma; ERAS-801 Has Now Received ODD In Addition To FDA Fast Track Designation

June 22, 4:02 PM

ERAS-801 has now received ODD in addition to FDA Fast Track DesignationInitial THUNDERBBOLT-1 Phase 1 monotherapy data in patients with recurrent GBM expected in H2 2023SAN DIEGO, June 22, 2023 (GLOBE NEWSWIRE) --

ERAS

1 minute read

Sarepta Therapeutics’ Therapy Becomes First To Score FDA Nod For Duchenne Muscular Dystrophy Gene Therapy

By Vandana Singh

June 22, 2:48 PM

The FDA has granted accelerated approval to closely watched Sarepta Therapeutics Inc's (NASDAQ: SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD) in ambulatory pediatric patients aged 4 through 5 years with a

SRPT

2 minute read

Cidara Therapeutics Receives FDA Fast Track Designation For CD388, A Novel Drug-Fc Conjugate Targeting Influenza A And B

By Bill Haddad

June 22, 8:01 AM

Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the U.S.

CDTX

1 minute read

Roivant Reports Chronic Period Data For RVT-3101 From TUSCANY-2 Phase 2b Study In Ulcerative Colitis; Phase 3 Once-Monthly Subcutaneous Dose Resulted In Improved Clinical Remission

By Bill Haddad

June 22, 7:35 AM

This is the first-ever long-duration data reported for an anti-TL1A antibody At the expected Phase 3 once-monthly subcutaneous dose in the overall population, RVT-3101 treatment resulted in improved Clinical

ROIV

2 minute read

Boehringer Ingelheim And Eli Lilly And Company Announces U.S. FDA Approves Jardiance For The Treatment Of Type 2 Diabetes In Children 10 Years And Older

By Happy Mohamed

June 21, 1:16 PM

- Empagliflozin is the first and only SGLT2 inhibitor approved for this patient population - More than 5,700 young people are diagnosed with type 2 diabetes annually in the U.S. RIDGEFIELD,

LLY

2 minute read

Why Are Aldeyra Therapeutics Shares Plummeting Today

By Vandana Singh

June 21, 12:43 PM

Aldeyra Therapeutics Inc (NASDAQ: ALDX) has received a Complete Response Letter from the FDA for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection) for

ALDX

1 minute read

DiaMedica Raises $37.5M Via Equity Offering, Aiding Development Activities For DM199

By Nabaparna Bhattacharya

June 21, 11:40 AM

DiaMedica Therapeutics Inc. (NASDAQ: DMAC) has entered into an agreement with accredited investors that have agreed to provide up to $37.5 million in gross proceeds through a

DMAC

2 minute read

Argenx’s Vyvgart Hytrulo Becomes First FDA Approved Subcutaneous Option For Generalized Myasthenia Gravis

By Vandana Singh

June 21, 9:56 AM

The FDA has approved Argenx SE's (NASDAQ: ARGX) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an injection for subcutaneous (SC) use for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine

ARGX

7 minute read

FDA Grants Full Approval For Blincyto To Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

By Happy Mohamed

June 21, 9:01 AM

Conversion From Accelerated to Full Approval Reinforces BLINCYTO as Standard of Care for Patients With Minimal Residual Disease at Baseline After Remission THOUSAND OAKS, Calif., June 21, 2023 /PRNewswire/ --

AMGN