Granules India achieves First-to-File status for generic Lumryz tablets in the US, enhancing its position in complex generics ...
Granules India secures sole FTF status for Sodium Oxybate ER, enhancing its position in the complex generics market.
Lupin’s ANDA received tentative FDA approval for four enzalutamide tablet strengths, with final approval deferred until ...
The FDA announced approval of generic Priftin tablets to treat two types of tuberculosis caused by Mycobacterium tuberculosis ...
FORT LAUDERDALE, FL / ACCESS Newswire / June 25, 2026 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company specializing in generic and specialty prescription ...
Lupin has received tentative approval from the Food and Drug Administration for enzalutamide tablets, 40 mg, 80 mg, 120 mg and 160 mg. Xtandi is used to treat certain types of pro ...
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in ...
Rifapentine is a cyclopentyl rifamycin antimycobacterial agent indicated for the treatment of active pulmonary tuberculosis and late tuberculosis infection.
The FDA has approved the first generic version of baloxavir marboxil tablets for the treatment and prevention of influenza.
FDA cleared generic rifapentine for active pulmonary TB (≥12 years) with susceptible isolates, requiring combination therapy with other active antitubercular agents. Authorization also covers LTBI (≥2 ...
Lupin said it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in strengths of 40 mg, 80 mg, ...
Lupin is releasing azilsartan medoxomil tablets, 40mg and 80mg, which is the generic of Azurity Pharmaceuticals’ Edarbi. Generic Edarbi is indicated for the treatment of hyperte ...