Drug Approval | September 21, 2021
U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others
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CLSA, a capital market and investment group organised an Investors’ Forum where five Indian pharma companies participated. Excerpts from the report
The trial will evaluate the efficacy of psilocybin in Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA). The data is expected in early 2022
The three-dose vaccine approved for EUA contains 2mg for each dose, whereas the two-dose plan will have 3mg in each dose.
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The company plans to enter the formulation business in January 2022. It has also opened a branch in Hyderabad to trade pharmaceutical chemicals
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
HTL will build, validate and operate a botulinum manufacturing facility in the US
Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022
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