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Strides receives USFDA approval for Ibuprofen OTC Oral Suspension

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Feb 24

Forge Biologics receives USFDA fast track, orphan drug, and rare pediatric disease designations

Forge Biologics receives FDA fast track, orphan drug, and rare pediatric disease designations for FBX-101 gene therapy for patients with krabbe disease ...
Feb 17

Lupin Launches Posaconazole Delayed-Release Tablets

Lupin & its AET Pharma US Inc. (part of Tiefenbacher Group) received an approval for its ANDA from the USFDA...
Feb 17

Sirnaomics announces first patient dosed In phase 2a study of STP705

The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA...
Jan 18

Janssen received U.S. FDA approval for DARZALEX FASPRO

Genmab announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (...
Jan 16

Strides receives USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Truvada Tablets, 200 mg/300 mg, of Gilead Sciences...
Jan 15

PFIZER’S XALKORI APPROVED BY USFDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS

XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people ...
Jan 15

Moleculin announces Annamycin receives USFDA orphan drug designation for soft tissue sarcomas

Annamycin is capable of reaching 6 to 34-fold higher levels of accumulation in the lungs than that of doxorubicin, the primary first-line chemotherapy ...
Dec 29

Pfizer's LORBRENA sNDA in previously untreated ALK-positive lung cancer accepted for priority review by U.S. FDA

LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumour mutations that drive resistance to current medications and to address ...
Dec 29

Lupin launches Meloxicam Capsules, received approval from USFDA

Meloxicam Capsules indicated for the management of osteoarthritis pain...
Dec 29

Lupin receives approval from US FDA for Colesevelam Hydrochloride tablets

Another USFDA approval for Lupin...
Dec 18

CNS Pharmaceuticals announces USFDA approval of IND application for its brain cancer drug candidate Berubicin

CNS Pharma will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed ...
Dec 18

Strides Pharma receives USFDA approval for Oxybutynin Chloride Tablets

The medication is used to treat overactive bladder and urinary conditions...
Dec 18

Zai Lab partner MacroGenics announces US FDA approval of MARGENZA for patients with pretreated metastatic HER2-positive breast cancer

The approval for MARGENZA was based on data from SOPHIA, a randomized Phase 3 clinical trial...
Dec 17

USFDA approves Roche’s OCREVUS shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with ...
Dec 15

Entera Bio announces US FDA approval of IND application for EB613

Entera Bio receives US FDA approval of IND application for EB613 – an oral human parathyroid hormone (1-34) for the treatment of osteoporosis ...
Dec 11

US FDA approves Saxenda for the treatment of obesity in adolescents aged 12-17

Novo Nordisk is offering a new treatment option for adolescents with obesity and their families in the US...
Dec 05

Alembic Pharmaceuticals announces USFDA Final Approval for Metolazone Tablets USP

Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA...
Dec 03

Roche receives USFDA emergency use authorization for new test to measure the level of SARS-CoV-2 antibodies

This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19...
Dec 03

Roche announces FDA approval of Gavreto for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations...
Dec 03

Lupin receives approval from USFDA for Penicillamine Tablets USP

Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis...
Dec 01

Polaryx Therapeutics receives both rare pediatric disease and orphan drug designations from US FDA

Polaryx Therapeutics has received from the US FDA both Rare Pediatric Disease and Orphan Drug designations for the treatment of GM2 gangliosidosis with PLX-300...
Nov 25

ARCA biopharma receives U.S. FDA fast track designation for AB201 as a potential treatment for COVID-19

ARCA believes that AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation...
Nov 24

AskBio and Selecta Biosciences receive orphan drug designation for MMA-101 to treat methylmalonic acidemia

AskBio and Selecta expect to initiate a Phase 1 clinical trial of MMA-101 and ImmTOR for patients with MMA in the first half of ...
Nov 21

Protagonist Therapeutics receives orphan drug designation from the EMA for PTG-300 in polycythemia vera

Protagonist Therapeutics has previously received orphan drug designation for the treatment of polycythemia vera from US FDA...
Oct 22

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