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zyntegloenhertufda aug26 The month of August witnessed the FDA approving the first cell-based gene therapy to treat adult and pediatric patients with beta-thalassemia who require regular blood transfusions on Aug.17. Now, let's take a look at the biotech stocks facing FDA decision in September.

fda jun24 On July 13, the FDA will decide whether or not to approve Regeneron Pharmaceuticals Inc.'s (REGN) REGEN-COV, proposed for the treatment of COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

prevnar jun08 On this day last year, i.e., June 8, 2021, the FDA approved Pfizer Inc.'s (PFE) Prevnar 20 vaccine to prevent pneumonia and invasive disease caused by 20 types of pneumococcal bacteria in adults 18 years of age and older.

bavarian nordic 052722 As another month comes to a close, it's time to take a look back at some of the healthcare sector news that made headlines in May and look ahead to what's in store on the regulatory front in June.

fda aprl27 The FDA decision on Amicus Therapeutics' (FOLD) New Drug Application for Miglustat, one of the two components of AT-GAA, proposed for adult patients with Pompe disease, is slated for May 29.

fda march28 An FDA panel is scheduled to review TG Therapeutics Inc.'s (TGTX) Biologics License Application/supplemental New Drug Application for the combination of Ublituximab and Ukoniq, known as the U2 regimen, on April 22, 2022. The U2 regimen is proposed for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

fda feb25 As another month comes to an end, it's time to take a look back at some of the regulatory news that made headlines in February and look ahead to what the month of March has in store.

solensiaomicorn 0125 In January, 2 novel drugs received the regulatory nod in the U.S., and they are Swiss biotech Idorsia Ltd.'s Quviviq to treat insomnia and Pfizer's Cibinqo to treat refractory, moderate-to-severe atopic dermatitis. Now, let's take a look at the biotech stocks facing FDA decision in February.

fda dec27 As another month comes to an end, we take a look back at some of the regulatory news that dominated the headlines in December and look ahead to what's in store for January.

podiumrankings dec22 Prevention is always better than cure. The year 2021 saw the global rollout of vaccines being accelerated for the prevention of a new disease. Yes, a disease that has been dominating the headlines since 2020 - Covid-19. It's no surprise that the Covid-19 vaccines find a place in the list of top-selling pharmaceuticals.

biomarin nov29 Just when everyone thought that the worst of the Covid-19 pandemic may be behind us, the emergence of Omicron, a new coronavirus variant, is causing global concern. Detected first in South Africa on November 24, 2021, Omicron cases have now been reported in at least 15 countries.

fda oct28 It's that time of month again when we take a look back at some of the regulatory news of October and look ahead to what's on the horizon for November.

pfizercovid sep30 The FDA approved 3 novel drugs in the month of September, bringing the total number of novel drug approvals so far this year to 39. Let's take a look at the biotech stocks facing FDA decision in October.

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